Therapy Detail

Therapy Name Erdafitinib
Synonym
Therapy Description

Balversa (erdafitinib) selectively inhibits FGFR1-4, resulting in decreased downstream signaling, and potentially leading to reduced growth of tumors with activated FGFR signaling (PMID: 28341788, PMID: 28965185). Balversa (erdafitinib) is FDA approved for use in patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Erdafitinib Balversa JNJ-42756493 FGFR Inhibitor (Pan) 18 Balversa (erdafitinib) selectively inhibits FGFR1-4, resulting in decreased downstream signaling, and potentially leading to reduced growth of tumors with activated FGFR signaling (PMID: 28341788, PMID: 28965185). Balversa (erdafitinib) is FDA approved for use in patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3-TACC3 glioblastoma multiforme predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a clinical study, Balversa (erdafitinib) treatment resulted in tumor reduction and stable disease in 2 glioblastoma multiforme patients harboring FGFR3-TACC3 fusion (PMID: 25609060). 25609060
FGFR3-TACC3 glioblastoma multiforme predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in partial response in a glioblastoma patient harboring FGFR3-TACC3 fusion (PMID: 26324363; NCT01703481). 26324363
FGFR3 R248C transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 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 (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail... detail...
FGFR2-OFD1 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR2-OFD1 in culture (PMID: 28416604). 28416604
FGFR1 amp lung cancer predicted - sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Balversa (erdafitinib) inhibited FGFR downstream signaling and proliferation of several lung cancer cell lines with FGFR1 amplification in culture, and inhibited tumor growth in an FGFR1-amplified lung cancer cell line xenograft model (PMID: 28341788). 28341788
FGFR3 mutant transitional cell carcinoma sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in 25% tumor shrinkage at week 8 in an urothelial cancer patient harboring FGFR3 mutations (PMID: 26324363; NCT01703481). 26324363
FGFR3 mutant transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail...
FGFR2-BICC1 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR2-BICC1 in culture (PMID: 28416604). 28416604
FGFR2-CCDC6 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR2-CCDC6 in culture (PMID: 28416604). 28416604
FGFR3 G370C transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 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 (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail... detail...
FGFR2 amp stomach cancer sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Balversa (erdafitinib) inhibited proliferation of a gastric cancer cell line with FGFR2 amplification in culture, and inhibited tumor growth in xenograft models (PMID: 28341788). 28341788
FGFR3-TACC3 non-small cell lung carcinoma sensitive Erdafitinib Preclinical - Pdx Actionable In a preclinical study, Balversa (erdafitinib) inhibited pERK signaling and tumor growth in a patient-derived xenograft (PDX) model of non-small cell lung cancer harboring FGFR3-TACC3 (PMID: 28341788). 28341788
FGFR3 N540K Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinicl study, Balversa (erdafitinib) inhibited proliferation of transformed cells expressing FGFR3 N540K in culture (PMID: 26992226). 26992226
FGFR1 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in stable disease in 70% (16/23) and partial response in 22% (5/23) of patients with advanced solid tumors harboring FGFR 1-4 activating mutations (including amplifications, mutations and translocations), while no antitumor activity was observed in patients with unknown or no known changes in FGFR (PMID: 26324363; NCT01703481). 26324363
FGFR3 K650E Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited proliferation of transformed cells expressing FGFR3 K560E in culture (PMID: 26992226). 26992226
FGFR2-BICC1 FGFR2-OFD1 endometrial cancer predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in partial response in an endometrial cancer patient harboring FGFR2-BICC1 and FGFR2-OFD1 fusions (PMID: 26324363; NCT01703481). 26324363
FGFR1 amp KRAS G12V lung cancer resistant Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, a lung cancer cell line harboring FGFR1 amplification and KRAS G12V demonstrated insensitivity to Balversa (erdafitinib) in culture (PMID: 28341788). 28341788
FGFR2-AFF3 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR2-AFF3 in culture (PMID: 28416604). 28416604
FGFR2-BICC1 FGFR2-CASP7 transitional cell carcinoma predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in partial response for more than 12 months in a urothelial cancer patient harboring FGFR2-BICC1 and FGFR2-CASP7 fusions (PMID: 26324363; NCT01703481). 26324363
FGFR3 Y373C transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 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 (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail... detail...
Unknown unknown Advanced Solid Tumor not applicable Erdafitinib Phase I Actionable In a Phase I study, Balversa (erdafitinib) displayed safety and efficacy in advanced solid tumor patients (J Clin Oncol 32:5s, 2014 (suppl; abstr 2501)). detail...
FGFR3-TACC3 transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable n a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 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-TACC3 fusion is included in the companion diagnostic (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail... detail...
FGFR3-TACC3 transitional cell carcinoma sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in partial response in 2 urothelial cancer patients harboring FGFR3-TACC3 (PMID: 26324363; NCT01703481). 26324363
FGFR1 mutant transitional cell carcinoma predicted - sensitive Erdafitinib Phase II Actionable In a Phase II trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail...
FGFR3-BAIAP2L1 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR3-BAIA2PL1 in culture (PMID: 28416604). 28416604
FGFR2 amp colorectal cancer sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Balversa (erdafitinib) inhibited tumor growth in an FGFR2-amplified colorectal cancer cell line xenograft model (PMID: 28341788). 28341788
FGFR3 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in stable disease in 70% (16/23) and partial response in 22% (5/23) of patients with advanced solid tumors harboring FGFR 1-4 activating mutations (including amplifications, mutations and translocations), while no antitumor activity was observed in patients with unknown or no known changes in FGFR (PMID: 26324363; NCT01703481). 26324363
FGFR3-TACC3 urinary bladder cancer predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in a partial response with 38% shrinkage of tumor in a patient with metastatic bladder cancer harboring FGFR3-TACC3, who stayed on treatment for 10 months (PMID: 28416604; NCT01703481). 28416604
FGFR2 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in stable disease in 70% (16/23) and partial response in 22% (5/23) of patients with advanced solid tumors harboring FGFR 1-4 activating mutations (including amplifications, mutations and translocations), while no antitumor activity was observed in patients with unknown or no known changes in FGFR (PMID: 26324363; NCT01703481). 26324363
FGFR2-CCDC6 FGFR3-TACC3 adrenal carcinoma predicted - sensitive Erdafitinib Case Reports/Case Series Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted tumor shrinkage and no disease progression for 10 months in an adrenal carcinoma patient harboring FGFR3-TACC3 and FGFR2-CCDC6 fusions (PMID: 26324363; NCT01703481). 26324363
FGFR2-CASP7 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited Fgfr phosphorylation and downstream signaling, resulted in growth inhibition of transformed cells expressing FGFR2-CASP7 in culture (PMID: 28416604). 28416604
FGFR1 amp KRAS amp lung cancer resistant Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, a lung cancer cell line with co-amplification of FGFR1 and KRAS demonstrated insensitivity to Balversa (erdafitinib) in culture (PMID: 28341788). 28341788
FGFR2 mutant transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail...
FGFR3 S249C transitional cell carcinoma sensitive Erdafitinib FDA approved Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 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 (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail... detail...
FGFR3-TACC3 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinical study, Balversa (erdafitinib) inhibited proliferation of transformed cells FGFR3-TACC3 in culture (PMID: 26992226). 26992226
FGFR3-TACC3 malignant glioma sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Balversa (erdafitinib) inhibited proliferation of glioma cells harboring FGFR3-TACC3 fusion in culture and xenograft tumor growth in animal models (PMID: 25609060). 25609060
Clinical Trial Phase Therapies Title Recruitment Status
NCT02365597 Phase II Erdafitinib An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial Cancer Active, not recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT03390504 Phase III Pembrolizumab Erdafitinib Docetaxel + Vinflunine A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Recruiting
NCT01703481 Phase I Erdafitinib A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Patients With Advanced or Refractory Solid Tumors or Lymphoma Completed
NCT03210714 Phase II Erdafitinib Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) Recruiting