Therapy Detail

Therapy Name Erdafitinib
Therapy Description

Erdafitinib (JNJ-42756493) selectively inhibits FGFR1-4, resulting in decreased downstream signaling, and potentially leading to reduced growth of tumors with activated FGFR signaling (PMID: 28341788).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Erdafitinib JNJ-42756493 FGFR Inhibitor (Pan) 17 Erdafitinib (JNJ-42756493) selectively inhibits FGFR1-4, resulting in decreased downstream signaling, and potentially leading to reduced growth of tumors with activated FGFR signaling (PMID: 28341788).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3-TACC3 malignant glioma sensitive Erdafitinib Preclinical Actionable In a preclinical study, Erdafitinib (JNJ-42756493) inhibited proliferation of glioma cells harboring FGFR3 - TACC3 fusion in culture and xenograft tumor growth in animal models (PMID: 25609060). 25609060
FGFR2 mutant transitional cell carcinoma predicted - sensitive Erdafitinib Phase II Actionable In a Phase II trial, Erdafitinib (JNJ-42756493) 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 fusion endometrial cancer sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response in an endometrial cancer patient harboring FGFR2 - BICC1 and FGFR2 - OFD1 fusions (PMID: 26324363). 26324363
FGFR1 mutant transitional cell carcinoma predicted - sensitive Erdafitinib Phase II Actionable In a Phase II trial, Erdafitinib (JNJ-42756493) 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...
FGFR1 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) 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). 26324363
FGFR3-TACC3 non-small cell lung carcinoma sensitive Erdafitinib Preclinical - Pdx Actionable In a preclinical study, Erdafitinib (JNJ-42756493) 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
Unknown unknown Advanced Solid Tumor not applicable Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring FGFR alterations (J Clin Oncol 32:5s, 2014 (suppl; abstr 2501)). detail...
Unknown unknown Advanced Solid Tumor not applicable Erdafitinib Phase I Actionable In a Phase I study, Erdafitinib (JNJ-42756493) displayed safety and efficacy in advanced solid tumor patients (J Clin Oncol 32:5s, 2014 (suppl; abstr 2501)). detail...
FGFR3 N540K Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinicl study, Erdafitinib (JNJ-42756493) inhibited proliferation of transformed cells over expressing FGFR3 K560E in culture (PMID: 26992226). 26992226
FGFR2 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) 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). 26324363
FGFR3 act mut Advanced Solid Tumor sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) 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). 26324363
FGFR3 mutant urinary system cancer sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in 25% tumor shrinkage at week 8 in an urothelial cancer patient harboring FGFR3 mutations (PMID: 26324363). 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 G13C demonstrated insensitivity to Erdafitinib (JNJ-42756493) in culture (PMID: 28341788). 28341788
FGFR2 amp colorectal cancer sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Erdafitinib (JNJ-42756493) inhibited tumor growth in an FGFR2-amplified colorectal cancer cell line xenograft model (PMID: 28341788). 28341788
FGFR3 K650E Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinicl study, Erdafitinib (JNJ-42756493) inhibited proliferation of transformed cells over expressing FGFR3 K560E in culture (PMID: 26992226). 26992226
FGFR3-TACC3 urinary system cancer sensitive Erdafitinib Phase I Actionable In a Phase I clinical trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response in 2 urothelial cancer patients harboring FGFR3-TACC3 (PMID: 26324363). 26324363
FGFR2 fusion urinary system cancer sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response for more than 12 months in a urothelial cancer patient harboring FGFR2 - BICC1 and FGFR2 - CASP7 fusions (PMID: 26324363). 26324363
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 Erdafitinib (JNJ-42756493) in culture (PMID: 28341788). 28341788
FGFR3-TACC3 glioblastoma multiforme sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response in a glioblastoma patient harboring FGFR3 - TACC3 fusion (PMID: 26324363). 26324363
FGFR3-TACC3 glioblastoma multiforme sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in tumor reduction and stable disease in 2 glioblastoma multiforme patients harboring FGFR3 - TACC3 fusion (PMID: 25609060). 25609060
FGFR1 amp lung cancer predicted - sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Erdafitinib (JNJ-42756493) 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 predicted - sensitive Erdafitinib Phase II Actionable In a Phase II trial, Erdafitinib (JNJ-42756493) 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 amp stomach cancer sensitive Erdafitinib Preclinical - Cell line xenograft Actionable In a preclinical study, JNJ-42756493 (erdafitinib) inhibited proliferation of a gastric cancer cell line with FGFR2 amplification in culture, and inhibited tumor growth in xenograft models (PMID: 28341788). 28341788
FGFR2 fusion FGFR3 - TACC3 adrenal carcinoma sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) 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). 26324363
FGFR3-TACC3 Advanced Solid Tumor sensitive Erdafitinib Preclinical - Cell culture Actionable In a preclinicl study, Erdafitinib (JNJ-42756493) inhibited proliferation of transformed cells over expressing FGFR3-TACC3 in culture (PMID: 26992226). 26992226
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
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 Pediatric MATCH: Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations Recruiting