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Therapy Name Pemigatinib
Synonyms
Therapy Description

Pemigatinib (INCB054828) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (Ann Oncol, 29 (suppl 8), October 2018, abstract 756P).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pemigatinib Pemazyre INCB54828|INCB054828 FGFR1 Inhibitor 23 FGFR2 Inhibitor 17 FGFR3 Inhibitor 12 Pemazyre (pemigatinib) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (PMID: 32203698). Pemazyre (pemigatinib) is FDA approved for use in patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 - BICC1 cholangiocarcinoma sensitive Pemigatinib Phase II Actionable In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response rate (ORR) of 35.5% (38/107, 3 complete response, 35 partial response) in patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, 29% (31/107) of the patients harbored FGFR2-BICC1 and achieved an ORR (32.3%, 10/31) and a median progression-free survival (6.80 vs 6.93 months) comparable to the entire group (PMID: 32203698; NCT02924376). 32203698
FGFR2 C382R Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 C382R were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - PPHLN1 Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2-PPHLN1 were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CLIP1 Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, Pemazyre (pemigatinib) treatment inhibited viability of a transformed cell line expressing FGFR2-CLIP1 in culture (PMID: 31371345). 31371345
FGFR2 fusion cholangiocarcinoma sensitive Pemigatinib Guideline Actionable Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org). 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...
FGFR1 S588T Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 S588T were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 S125L Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 S125L were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 R809Q Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 R809Q were sensitive to treatment with AZD4547 in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - PAWR cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-PAWR resulted in a partial response with a decrease in tumor size of 39.8% and progression-free survival of 6.9 months (PMID: 33218975; NCT02924376). 33218975
FGFR2 - SHTN1 Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2-SHTN1 were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 P483L Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 P483L were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 - TACC1 Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1-TACC1 were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - KIAA1217 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-KIAA1217 resulted in a partial response with a decrease in tumor size of 60.5% and progression-free survival of 15.9 months (PMID: 33218975; NCT02924376). 33218975
FGFR1 D128N Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 D128N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - AHCYL1 Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2-AHCYL1 were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CCDC6 Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2-CCDC6 were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 C62Y Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 C62Y were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - TRIM8 FGFR2 E565A FGFR2 L617V FGFR2 K659M cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-TRIM8 experienced disease progression after 9.1 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 E565A, FGFR2 L617V, and FGFR2 K659M (PMID: 33218975; NCT02924376). 33218975
FGFR1 S238N Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 S238N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR3 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell line xenograft Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR1 rearrange myeloid and lymphoid neoplasms associated with FGFR1 abnormalities sensitive Pemigatinib Guideline Actionable Pemazyre (pemigatinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). detail...
FGFR2 - KIAA1217 FGFR2 K659M cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-KIAA1217 experienced disease progression after 15.9 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 K659M (PMID: 33218975; NCT02924376). 33218975
FGFR2 D101Y Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 D101Y were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 A121D Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 A121D were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 E160K Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 E160K were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 T340M Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 T340M were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CCDC170 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-CCDC170 resulted in a partial response with a decrease in tumor size of 58.2% and progression-free survival of 6.9 months (PMID: 33218975; NCT02924376). 33218975
FGFR2 N549S Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 N549S were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 R6P Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 R6P were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 M186T Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 M186T were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - WDHD1 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-WDHD1 resulted in a partial response with a decrease in tumor size of 63.6% and progression-free survival of 8.8 months (PMID: 33218975; NCT02924376). 33218975
FGFR1 A268S Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 A268S were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 T26I Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 T26I were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 Y375C Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 Y375C were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CLIP1 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a clinical case study, a cholangiocarinoma patient harboring FGFR2-CLIP1 demonstrated a partial response following treatment with Pemazyre (pemigatinib) (PMID: 31371345). 31371345
FGFR1 R475Q Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 R475Q were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR2 E163K Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 E163K were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 D320N Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 D320N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 E592G Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 E592G were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 K659N Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 K659N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CLIP1 FGFR2 N549H cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a clinical case study, a cholangiocarinoma patient harboring FGFR2-CLIP1 demonstrated an initial partial response following treatment with Pemazyre (pemigatinib), but progressed after 5 months, and was determined to have an acquired FGFR2 N549H mutation (PMID: 31371345). 31371345
FGFR1 R250W Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 R250W were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 E467K Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 E467K were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 S252W Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 S252W were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - TRIM8 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-TRIM8 resulted in a partial response with a decrease in tumor size of 46% and progression-free survival of 9.1 months (PMID: 33218975; NCT02924376). 33218975
FGFR1 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell line xenograft Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR2 - AHCYL1 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-AHCYL1 resulted in stable disease with a decrease in tumor size of 33.3% and progression-free survival of 6.8 months (PMID: 33218975; NCT02924376). 33218975
FGFR1 N546K Advanced Solid Tumor predicted - resistant Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 N546K were resistant to treatment with Pemazyre (pemigatinib) in culture (PMID: 34272467). 34272467
FGFR1 D128V Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 D128V were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - NRBF2 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-NRBF2 resulted in stable disease with a decrease in tumor size of 15.7% and progression-free survival of 13.1 months (PMID: 33218975; NCT02924376). 33218975
FGFR1 A21T Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 A21T were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 L33S Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 L33S were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 T141R Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical Actionable In a preclinical study, cells expressing FGFR1 T141R were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 K656E Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 K656E were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 G703S Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 G703S were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - CCDC170 FGFR2 N549K FGFR2 K641R cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-CCDC170 experienced disease progression after 6.9 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 N549K and FGFR2 K641R (PMID: 33218975; NCT02924376). 33218975
FGFR2 rearrange cholangiocarcinoma sensitive Pemigatinib Guideline Actionable Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org). detail...
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...
FGFR2 A67V Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 A67V were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR3 G380R Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR3 G380R were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 N549D Advanced Solid Tumor resistant Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 N549D were resistant to treatment with Pemazyre (pemigatinib) in culture (PMID: 34272467). 34272467
FGFR2 R203C Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 R203C were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 N549K Advanced Solid Tumor resistant Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 N549K were resistant to treatment with Pemazyre (pemigatinib) in culture (PMID: 34272467). 34272467
FGFR2 - CLIP1 FGFR2 N549H Advanced Solid Tumor resistant Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, a transformed cell line expressing both FGFR2-CLIP1 and FGFR2 N549H demonstrated resistance to Pemazyre (pemigatinib) treatment in culture (PMID: 31371345). 31371345
FGFR1 S436F Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 S436F were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - AHCYL1 FGFR2 L617V cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-AHCYL1 experienced disease progression after 6.8 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 L617V (PMID: 33218975; NCT02924376). 33218975
FGFR1 D133N Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 D133N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - NRBF2 FGFR2 N549K cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-NRBF2 experienced disease progression after 13.1 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 N549K (PMID: 33218975; NCT02924376). 33218975
FGFR2 - ATAD2 cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), Pemazyre (pemigatinib) treatment in a cholangiocarcinoma patient harboring FGFR2-ATAD2 resulted in stable disease with a decrease in tumor size of 13% and progression-free survival of 8.8 months (PMID: 33218975; NCT02924376). 33218975
FGFR3 A391E Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR3 A391E were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 V751A Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 V751A were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 P150S Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 P150S were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 N82K Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR2 N82K were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 R445W Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 R445W were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 M456V Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 M456V were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR3 K650N Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR3 K650N were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR1 T319A Advanced Solid Tumor predicted - sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing FGFR1 T319A were sensitive to treatment with Pemazyre (pemigatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). 34272467
FGFR2 - ATAD2 FGFR2 N549H cholangiocarcinoma predicted - resistant Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-202), a cholangiocarcinoma patient harboring FGFR2-ATAD2 experienced disease progression after 8.8 months of treatment with Pemazyre (pemigatinib), and was found to have acquired FGFR2 N549H (PMID: 33218975; NCT02924376). 33218975

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02872714 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Active, not recruiting USA 10
NCT04591431 Phase II Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) Recruiting 1
NCT04294277 Phase II Pemigatinib Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) Recruiting 1
NCT03914794 Phase II Pemigatinib A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors Recruiting USA 0
NCT04003623 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) Active, not recruiting USA 0
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Recruiting USA 0
NCT03656536 Phase III Pemigatinib Cisplatin + Gemcitabine A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302) Recruiting USA | CAN 17
NCT02924376 Phase II Pemigatinib Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy Completed USA 11
NCT03822117 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) Active, not recruiting USA 10
NCT04949191 Phase II Pemigatinib Pembrolizumab + Pemigatinib Pemigatinib + Retifanlimab The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. Recruiting USA 0
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