BRAF V600E
|
melanoma
|
sensitive
|
Cobimetinib + Vemurafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, and BRAF V600E and BRAF V600K are on the companion diagnostic (PMID: 27480103; NCT01689519).
|
27480103
detail...
detail...
|
FLT3 I836X
|
acute myeloid leukemia
|
sensitive
|
Gilteritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (FDA.gov; NCT02421939).
|
detail...
detail...
|
FGFR3 S249C
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 S249C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
FGFR2 fusion
|
cholangiocarcinoma
|
sensitive
|
Infigratinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial that supported FDA approval, Truseltiq (infigratinib) treatment demonstrated manageable toxicity, resulted in an objective response rate of 23.1% (25/108, 1 complete response, 24 partial responses) in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 fusion or rearrangement, with a median duration of response of 5.0 months and a median progression-free survival of 7.3 months (J Clin Oncol 39, no. 3_suppl (January 20, 2021) 265-265; NCT02150967).
|
detail...
detail...
detail...
|
IDH1 R132H
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132H/C/G/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
PALB2 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including PALB2 (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
ATM inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious BRCA or ATM mutations, HR for progression or death was 1.04 in ATM-mutant patients (PMID: 32343890; NCT02987543).
|
detail...
32343890
detail...
|
MLH1 negative
|
endometrial cancer
|
sensitive
|
Dostarlimab-gxly
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284).
|
detail...
33001143
detail...
|
FGFR3 G370C
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 G370C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
BRAF V600K
|
melanoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (COMBI-v) that supported FDA approval, the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) resulted in an improved overall survival rate at 12 months (72% vs 65%, HR=0.69, p=0.005), median progression-free survival (11.4 vs 7.3 months, HR=0.56, p<0.001), and objective response rate (64% vs 51%, p<0.001) compared to Zelboraf (vemurafenib) in melanoma patients harboring BRAF V600E or V600K (PMID: 25399551; NCT01597908).
|
detail...
25399551
detail...
|
ROS1 rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Crizotinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial (PROFILE 1001) that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (38/53), with 6 complete responses and 32 partial responses, a median duration of response of 24.7 months, a median progression-free survival of 19.3 months, and a median overall survival of 51.4 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 30980071; NCT00585195).
|
detail...
detail...
30980071
|
BRAF V600E
|
melanoma
|
sensitive
|
Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (METRIC) that supported FDA approval, Mekinist (trametinib) treatment, as compared to Deticine (dacarbazine) or Taxol (paclitaxel) treatment, resulted in improved progression-free survival of 4.8 months versus 1.5 months and an overall six month survival rate of 81% versus 67% in patients with BRAF V600E/K-positive metastatic melanoma (PMID: 22663011; NCT01245062).
|
22663011
detail...
detail...
|
BRAF V600E
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453).
|
detail...
30219628
detail...
detail...
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Lorlatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial that supported FDA approval, Lorbrena (lorlatinib) treatment resulted in an objective response (OR) rate of 47% (93/198; 4 CR, 89 PR) and a median time to overall first tumor response of 1.4 months, and an objective intracranial response rate of 63% (51/81) and median time to first intracranial response of 1.4 months in ALK-positive (rearrangement or fusion) non-small cell lung cancer patients who had received at least one prior ALK inhibitor therapy (PMID: 30413378; NCT01970865).
|
detail...
30413378
detail...
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Lorlatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (Study B7461006) that supported FDA approval, Lorbrena (lorlatinib) treatment significantly improved 12-month progression-free survival rate (78% vs 39%, HR 0.28, p<0.001) compared to Xalkori (crizotinib) in patients with advanced ALK-positive non-small cell lung cancer who had no prior systemic therapy, objective response rate was 82% (57/69) with 71% achieved complete intracranial response in patients with brain metastasis (PMID: 33207094; NCT03052608).
|
33207094
detail...
detail...
|
IDH2 R140Q
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R140Q is on the companion diagnostic.
|
detail...
detail...
28588020
|
FLT3 exon 15 ins
|
acute myeloid leukemia
|
sensitive
|
Gilteritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD; exon 14 insertion, exon 15 insertion), D835, or I836 mutation (FDA.gov; NCT02421939).
|
detail...
detail...
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Crizotinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140).
|
detail...
25470694
detail...
|
ROS1 fusion
|
lung non-small cell carcinoma
|
sensitive
|
Crizotinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (36/50), with 3 complete responses and 33 partial responses, a median duration of response of 17.6 months, and a median progression-free survival of 19.2 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 25264305; NCT00585195).
|
detail...
25264305
detail...
|
FGFR3 Y373C
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 Y373C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
FGFR3 S249C
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 S249C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453).
|
detail...
detail...
detail...
30219628
|
BRIP1 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including BRIP1 (PMID: 32343890; NCT02987543).
|
detail...
32343890
detail...
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Ceritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Zykadia (ceritinib) resulted in a blinded independent review committee (BIRC)-assessed objective response rate of 44% (72/163) and a duration of response of 7.1 months in ALK-rearranged non-small cell lung cancer patients (PMID: 25754348; NCT01283516).
|
25754348
detail...
detail...
|
IDH1 R132H
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
32416072
detail...
|
IDH1 R132S
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).
|
detail...
29860938
detail...
|
FLT3 mutant
|
acute myeloid leukemia
|
sensitive
|
Gilteritinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (FDA.gov; NCT02421939).
|
detail...
detail...
|
IDH1 R132S
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
detail...
29860938
detail...
|
IDH2 R140L
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R140L is on the companion diagnostic.
|
detail...
detail...
28588020
|
FGFR2 mutant
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
IDH1 R132S
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
35443108
detail...
detail...
|
IDH1 R132G
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).
|
detail...
29860938
detail...
|
IDH1 R132L
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
32416072
detail...
|
IDH1 R132L
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
29860938
detail...
detail...
|
FGFR3 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Brigatinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in superior progression-free survival (HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in patients with ALK-rearrangement positive metastatic non-small cell lung cancer (Ann Oncol., Apr 2019, 30 (Suppl 2):ii48; NCT02737501).
|
detail...
detail...
detail...
|
MSH6 negative
|
endometrial cancer
|
sensitive
|
Dostarlimab-gxly
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284).
|
detail...
33001143
detail...
|
IDH2 mutant
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (R140Q/L/G/W, R172K/M/G/S/W) (PMID: 28588020; NCT01915498).
|
28588020
detail...
detail...
|
CHEK2 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.87 in CHEK2-mutant patients (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Lorlatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial that supported FDA approval, Lorbrena (lorlatinib) treatment resulted in an objective response (OR) rate of 47% (93/198; 4 CR, 89 PR) and a median time to overall first tumor response of 1.4 months, and an objective intracranial response rate of 63% (51/81) and median time to first intracranial response of 1.4 months in ALK-positive (rearrangement or fusion) non-small cell lung cancer patients who had received at least one prior ALK inhibitor therapy (PMID: 30413378; NCT01970865).
|
detail...
detail...
30413378
|
IDH1 R132G
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
35443108
detail...
detail...
|
FLT3 D835X
|
acute myeloid leukemia
|
sensitive
|
Gilteritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (FDA.gov; NCT02421939).
|
detail...
detail...
|
BRAF V600E
|
melanoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (COMBI-v) that supported FDA approval, the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) resulted in an improved overall survival rate at 12 months (72% vs 65%, HR=0.69, p=0.005), median progression-free survival (11.4 vs 7.3 months, HR=0.56, p<0.001), and objective response rate (64% vs 51%, p<0.001) compared to Zelboraf (vemurafenib) in melanoma patients harboring BRAF V600E or V600K (PMID: 25399551; NCT01597908).
|
detail...
detail...
25399551
|
IDH1 R132C
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
IDH1 mutant
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
detail...
35443108
detail...
|
FLT3 mutant
|
acute myeloid leukemia
|
sensitive
|
Cytarabine + Daunorubicin + Midostaurin
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (HR=0.78, p=0.009) and event-free survival (HR=0.78, p=0.002) in patients with FLT3-mutant (ITD, D835X, and I836X mutations) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114; NCT00651261).
|
28644114
detail...
detail...
|
IDH2 R172M
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R172M is on the companion diagnostic.
|
28588020
detail...
detail...
|
BRAF V600E
|
melanoma
|
sensitive
|
Vemurafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (BRIM-3) that supported FDA approval, Zelboraf (vemurafenib), as compared to Deticene (dacarbazine), resulted in an improved overall survival (OS) (13.6 vs 9.7 months, HR=0.81, p=0.03) in patients with BRAF V600E-positive metastatic melanoma, with estimated OS rates of 56%, 30%, 21%, and 17% at 1, 2, 3, and 4 years, respectively (PMID: 28961848, PMID: 21639808; NCT01006980), and BRAF V600E is included on the companion diagnostic (FDA.gov).
|
28961848
detail...
detail...
21639808
|
FANCL inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including FANCL (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
FLT3 D835X
|
acute myeloid leukemia
|
sensitive
|
Cytarabine + Daunorubicin + Midostaurin
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114).
|
detail...
28644114
detail...
|
MLH1 negative
|
endometrial carcinoma
|
sensitive
|
Pembrolizumab
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067).
|
detail...
34990208
detail...
|
BRAF V600K
|
melanoma
|
sensitive
|
Cobimetinib + Vemurafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, and BRAF V600E and BRAF V600K are on the companion diagnostic (PMID: 27480103; NCT01689519).
|
detail...
27480103
detail...
|
FGFR3 Y373C
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 Y373C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
IDH1 R132C
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
detail...
detail...
detail...
29860938
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453) and both BRAF V600E and V600K are on the companion diagnostic.
|
29573941
detail...
detail...
detail...
|
IDH1 R132L
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132L/C/G/H/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
IDH1 R132C
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
35443108
detail...
detail...
|
RAD51C inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51C (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Crizotinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140).
|
25470694
detail...
detail...
|
FLT3 exon 14 ins
|
acute myeloid leukemia
|
sensitive
|
Gilteritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD; exon 14 insertion), D835, or I836 mutation (FDA.gov; NCT02421939).
|
detail...
detail...
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Alectinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial supporting FDA approval (ALEX), Alecensa (alectinib) treatment resulted in improved rate of progression-free survival compared to Xalkori (crizotinib) (68.4% vs 48.7%, HR=0.47), and median progression-free survival (25.7 vs 10.4 months) in non-small cell lung cancer patients harboring ALK rearrangements (PMID: 28586279; NCT02075840).
|
detail...
28586279
detail...
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (METRIC) that supported FDA approval, Mekinist (trametinib) treatment, as compared to Deticine (dacarbazine) or Taxol (paclitaxel) treatment, resulted in improved progression-free survival of 4.8 months versus 1.5 months and an overall six month survival rate of 81% versus 67% in patients with BRAF V600E/K positive metastatic melanoma (PMID: 22663011; NCT01245062).
|
22663011
detail...
detail...
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Lorlatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (Study B7461006) that supported FDA approval, Lorbrena (lorlatinib) treatment significantly improved 12-month progression-free survival rate (78% vs 39%, HR 0.28, p<0.001) compared to Xalkori (crizotinib) in patients with advanced ALK-positive non-small cell lung cancer who had no prior systemic therapy, objective response rate was 82% (57/69) with 71% achieved complete intracranial response in patients with brain metastasis (PMID: 33207094; NCT03052608).
|
33207094
detail...
detail...
|
FGFR2 rearrange
|
cholangiocarcinoma
|
sensitive
|
Infigratinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial that supported FDA approval, Truseltiq (infigratinib) treatment demonstrated manageable toxicity, resulted in an objective response rate of 23.1% (25/108, 1 complete response, 24 partial responses) in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 fusion or rearrangement, with a median duration of response of 5.0 months and a median progression-free survival of 7.3 months (J Clin Oncol 39, no. 3_suppl (January 20, 2021) 265-265; NCT02150967).
|
detail...
detail...
detail...
|
FLT3 exon 14 ins
|
acute myeloid leukemia
|
sensitive
|
Cytarabine + Daunorubicin + Midostaurin
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114).
|
28644114
detail...
detail...
|
FGFR2 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
BRAF V600E
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453), and both BRAF V600E and V600K are on the companion diagnostic.
|
29573941
detail...
detail...
detail...
|
IDH1 R132S
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132S/C/G/H/L) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
BARD1 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including BARD1 (PMID: 32343890; NCT02987543).
|
detail...
32343890
detail...
|
IDH1 R132H
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
29860938
detail...
detail...
|
BRAF V600E
|
lung non-small cell carcinoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial that supported FDA approval, treatment with the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) in patients with non-small cell lung cancer harboring BRAF V600E resulted in an overall response rate of 66.7% (38/57) in previously treated patients and 64% (23/36) in untreated patients, versus 33% (26/78) treated with Tafinlar (dabrafenib) alone (PMID: 27080216, PMID: 27283860, PMID: 28919011; NCT01336634).
|
27283860
detail...
27080216
detail...
detail...
28919011
|
IDH1 mutant
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
detail...
detail...
29860938
|
BRAF V600E
|
thyroid gland anaplastic carcinoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (ROAR) that supported FDA approval, the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) resulted in an overall response rate of 61% (20/33; 3 complete responses, 17 partial responses) in patients with anaplastic thyroid cancer harboring BRAF V600E, with 12-month duration of response rate of 50%, a median progression-free survival and overall survival of 6.7 and 14.5 months, respectively (PMID: 35026411; NCT02034110).
|
35026411
detail...
detail...
detail...
|
RAD54L inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.33 in RAD54L-mutant patients (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
IDH1 mutant
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
FGFR3 G370C
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 G370C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
FGFR3 R248C
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 R248C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
RET fusion
|
thyroid gland cancer
|
sensitive
|
Selpercatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial (LIBRETTO-001) that supported FDA approval, Retevmo (selpercatinib) treatment resulted in an objective response rate of 79% (15/19), including one complete and 14 partial responses, with a median response duration of 18.4 months, and median progression-free survival of 20.1 months in adult and pediatric patients 12 years and older with RET fusion-positive thyroid cancer who were previously treated (PMID: 32846061; NCT03157128).
|
detail...
detail...
32846061
|
IDH1 R132C
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).
|
detail...
29860938
detail...
|
IDH1 R132H
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).
|
29860938
detail...
detail...
|
IDH2 R172S
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R172S is on the companion diagnostic.
|
28588020
detail...
detail...
|
RET fusion
|
lung non-small cell carcinoma
|
sensitive
|
Pralsetinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial (ARROW) that supported FDA approval, Gavreto (pralsetinib) treatment was well-tolerated, resulting in an objective response rate of 61% (53/87) and 70% (19/27) in previously treated and treatment-naive patients with RET fusion-positive non-small cell lung cancer, respectively (PMID: 34118197; NCT03037385).
|
detail...
34118197
detail...
|
BRAF V600E
|
melanoma
|
sensitive
|
Dabrafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III clinical trial (BREAK-3) that supported FDA approval, Tafinlar (dabrafenib) improved median progression-free survival compared to Deticene (dacarbazine) (5.1 vs 2.7 months, HR=0.3, p<0.0001) in patients with BRAF V600E positive melanoma (PMID: 22735384; NCT01227889).
|
detail...
detail...
22735384
|
IDH2 R140G
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R140G is on the companion diagnostic.
|
detail...
detail...
28588020
|
IDH1 R132G
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).
|
detail...
29860938
detail...
|
NRAS wild-type
|
colorectal cancer
|
predicted - sensitive
|
Panitumumab
|
FDA approved - On Companion Diagnostic |
Actionable |
Vectibix (panitumumab) is FDA approved for metastatic colorectal patients that are NRAS wild-type, as detected by a companion diagnostic (FDA.gov).
|
detail...
detail...
|
MSH6 negative
|
Advanced Solid Tumor
|
sensitive
|
Dostarlimab-gxly
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial (GARNET) that supported FDA aproval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 41.6% (87/209), with a median duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2564-2564; NCT02715284).
|
detail...
detail...
detail...
|
IDH1 R132L
|
acute myeloid leukemia
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).
|
29860938
detail...
detail...
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Brigatinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in superior progression-free survival (HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in patients with ALK-rearrangement positive metastatic non-small cell lung cancer (Ann Oncol., Apr 2019, 30 (Suppl 2):ii48; NCT02737501).
|
detail...
detail...
detail...
|
IDH1 R132G
|
acute myeloid leukemia
|
sensitive
|
Olutasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132G/C/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574).
|
detail...
detail...
detail...
|
IDH2 R172K
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R172K is on the companion diagnostic.
|
detail...
detail...
28588020
|
IDH1 R132L
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
35443108
detail...
detail...
|
IDH2 R172W
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R172W is on the companion diagnostic.
|
28588020
detail...
detail...
|
RAD51B inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51B (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
FLT3 I836X
|
acute myeloid leukemia
|
sensitive
|
Cytarabine + Daunorubicin + Midostaurin
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114).
|
detail...
detail...
28644114
|
IDH1 R132S
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
detail...
32416072
|
IDH1 R132G
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
32416072
detail...
|
BRAF V600K
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453) and both BRAF V600E and BRAF V600K are on the companion diagnostic.
|
29573941
detail...
detail...
detail...
|
BRAF V600K
|
melanoma
|
sensitive
|
Binimetinib + Encorafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453).
|
detail...
30219628
detail...
detail...
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (COMBI-v) that supported FDA approval, the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) resulted in an improved overall survival rate at 12 months (72% vs 65%, HR=0.69, p=0.005), median progression-free survival (11.4 vs 7.3 months, HR=0.56, p<0.001), and objective response rate (64% vs 51%, p<0.001) compared to Zelboraf (vemurafenib) in melanoma patients harboring BRAF V600E or V600K (PMID: 25399551; NCT01597908).
|
detail...
detail...
25399551
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Dabrafenib + Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (COMBI-AD) that supported FDA approval, adjuvant treatment with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) resulted in an improved estimated 3-year relapse-free survival rate (58% vs 39%, HR=0.47, P<0.001) and 3-year overall survival rate (86% vs 77%, HR=0.57; 95% CI, 0.42 to 0.79, P=0.0006) compared to placebo in stage III melanoma patients harboring BRAF V600E or V600K mutations (PMID: 28891408; NCT01682083).
|
detail...
28891408
detail...
|
RET mutant
|
thyroid gland medullary carcinoma
|
sensitive
|
Selpercatinib
|
FDA approved |
Actionable |
In a Phase I/II trial (LIBRETTO-001) that supported FDA approval, Retevmo (selpercatinib) treatment resulted in an objective response rate (ORR) of 69% (38/55), with five complete and 33 partial responses, in adult and pediatric patients of 12 years and older with medullary thyroid cancer harboring RET mutations who were previously treated, while patients who had not been previously treated demonstrated an ORR of 73% (64/88), with ten complete and 54 partial responses (PMID: 32846061; NCT03157128).
|
detail...
detail...
32846061
|
IDH2 R172G
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R172G is on the companion diagnostic.
|
28588020
detail...
detail...
|
IDH1 R132C
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
detail...
32416072
|
FGFR3 R248C
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations and FGFR3 R248C is included in the companion diagnostic (PMID: 31340094; NCT02365597).
|
31340094
detail...
detail...
|
CDK12 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.74 in CDK12-mutant patients (PMID: 32343890; NCT02987543).
|
detail...
32343890
detail...
|
CHEK1 inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including CHEK1 (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|
BRAF V600E/K
|
melanoma
|
sensitive
|
Cobimetinib + Vemurafenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, and BRAF V600E and BRAF V600K are on the companion diagnostic (PMID: 27480103; NCT01689519).
|
detail...
detail...
27480103
|
MSH6 negative
|
endometrial carcinoma
|
sensitive
|
Pembrolizumab
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067).
|
detail...
detail...
34990208
|
FGFR3 mutant
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
RET fusion
|
lung non-small cell carcinoma
|
sensitive
|
Selpercatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial (LIBRETTO-001) that supported FDA approval, Retevmo (selpercatinib) treatment resulted in an objective response rate (ORR) of 64% (64/105) in patients with RET fusion-positive non-small cell lung cancer, with a median duration of response of 17.5 months, ORR was 85% (33/39) and 91% (10/11) in previously treated patients and patients with measurable CNS metastasis, respectively (PMID: 32846060; NCT03157128).
|
detail...
32846060
detail...
|
MLH1 negative
|
Advanced Solid Tumor
|
sensitive
|
Dostarlimab-gxly
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 41.6% (87/209), with a median duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2564-2564; NCT02715284).
|
detail...
detail...
detail...
|
ALK rearrange
|
lung non-small cell carcinoma
|
sensitive
|
Alectinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial supporting FDA approval (ALEX), Alecensa (alectinib) treatment resulted in improved rate of progression-free survival compared to Xalkori (crizotinib) (68.4% vs 48.7%, HR=0.47), and median progression-free survival (25.7 vs 10.4 months) in non-small cell lung cancer patients harboring ALK rearrangement (PMID: 28586279; NCT02075840).
|
28586279
detail...
detail...
|
IDH1 mutant
|
cholangiocarcinoma
|
sensitive
|
Ivosidenib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).
|
detail...
detail...
32416072
|
IDH1 R132H
|
acute myeloid leukemia
|
sensitive
|
Azacitidine + Ivosidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248).
|
35443108
detail...
detail...
|
ALK fusion
|
lung non-small cell carcinoma
|
sensitive
|
Ceritinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I trial that supported FDA approval, Zykadia (ceritinib) resulted in a blinded independent review committee (BIRC)-assessed objective response rate of 44% (72/163) and a duration of response of 7.1 months in ALK-rearranged non-small cell lung cancer patients (PMID: 25754348; NCT01283516).
|
detail...
detail...
25754348
|
FGFR2 rearrange
|
cholangiocarcinoma
|
sensitive
|
Pemigatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376).
|
detail...
32203698
detail...
|
BRAF V600K
|
melanoma
|
sensitive
|
Trametinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (METRIC) that supported FDA approval, Mekinist (trametinib) treatment, as compared to Deticine (dacarbazine) or Taxol (paclitaxel) treatment, resulted in improved progression-free survival of 4.8 months versus 1.5 months and an overall six month survival rate of 81% versus 67% in patients with BRAF V600E/K-positive metastatic melanoma (PMID: 22663011; NCT01245062).
|
22663011
detail...
detail...
|
FGFR2 fusion
|
cholangiocarcinoma
|
sensitive
|
Pemigatinib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376).
|
detail...
32203698
detail...
|
IDH2 R140W
|
acute myeloid leukemia
|
sensitive
|
Enasidenib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase I/II trial that supported FDA approval, Idhifa (enasidenib) treatment resulted in an overall response rate of 40.3% (71/176) with a median response duration of 5.8 months, complete remission in 19.3% (34/176), and stable disease in 48.3% (85/176) of acute myeloid leukemia patients harboring IDH2 mutations (PMID: 28588020; NCT01915498) and IDH2 R140W is on the companion diagnostic.
|
detail...
detail...
28588020
|
RAD51D inact mut
|
prostate cancer
|
sensitive
|
Olaparib
|
FDA approved - On Companion Diagnostic |
Actionable |
In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51D (PMID: 32343890; NCT02987543).
|
detail...
detail...
32343890
|