Molecular Profile Detail

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Profile Name FGFR3 act mut
Gene Variant Detail

FGFR3 act mut (gain of function)

Relevant Treatment Approaches FGFR Inhibitor (Pan) FGFR3 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 act mut Advanced Solid Tumor sensitive FGFR3 Inhibitor Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR3 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). detail...
FGFR3 act mut Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) Ponatinib Preclinical Actionable In a preclinical study, Iclusig (ponatinib) inhibited receptor phosphorylation and cell growth in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) Dovitinib Preclinical Actionable In a preclinical study, Dovitinib (TKI258) inhibited receptor phosphorylation and cell proliferation in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor decreased response Cediranib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to inhibition of receptor phosphorylation and cell proliferation by Cediranib (AZD-2171) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor decreased response FGFR Inhibitor (Pan) Nintedanib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor no benefit Brivanib Preclinical Actionable In a preclinical study, Brivanib (BMS-540215) did not inhibit receptor phosphorylation and cell proliferation in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) 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 act mut urinary bladder cancer predicted - sensitive FGFR3 Inhibitor S-49076 Preclinical Actionable In a preclinical study, S-49076 inhibited autophosphorylation of FGFR3 and downstream signaling in bladder cancer cells over expressing constitutively active FGFR3 in culture (PMID: 23804704). 23804704
FGFR3 act mut Advanced Solid Tumor predicted - sensitive FGFR3 Inhibitor AZD4547 Phase II Actionable In a Phase II (MATCH) trial, AZD4547 treatment resulted in an overall response rate of 10.5% (2/19) in patients with advanced solid tumors harboring FGFR2 or 3 activating single nucleotide variants and a 6-month progression-free survival rate of 6%, with a partial response in 1 and stable disease in 2 of 7 patients with FGFR3 activating mutations (PMID: 32463741; NCT02465060). 32463741
FGFR3 act mut bladder urothelial carcinoma sensitive FGFR Inhibitor (Pan) Erdafitinib Guideline Actionable Balversa (erdafitinib) is included in guidelines for patients with advanced or metastatic bladder urothelial carcinoma harboring FGFR alterations (PMID: 34861372; ESMO.org). detail... 34861372
FGFR3 act mut Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase II Actionable In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 29.5% (64/217, 6 complete and 58 partial responses), a disease control rate of 74%, clinical benefit rate of 46%, a median duration of response of 6.9 months, median progression-free survival of 4.2 months, and median overall survival of 10.7 months in patients with advanced solid tumors harboring FGFR1, FGFR2, or FGFR3 mutations or fusions (PMID: 37541273; NCT04083976). 37541273
FGFR3 act mut transitional cell carcinoma sensitive FGFR3 Inhibitor Pemigatinib Phase II Actionable In a Phase II trial (FIGHT-201), Pemazyre (pemigatinib) treatment resulted in an objective response rate (ORR) of 17.8%, median duration of response (mDOR) of 6.2 mo, median progression-free survival (mPFS) of 4.0 mo, and median overall survival (mOS) of 6.8 mo with continuous dosing, and an ORR of 23.3%, mDOR of 6.2 mo, mPFS of 4.3 mo, and mOS of 8.9 mo with intermittent dosing in patients with urothelial carcinoma harboring FGFR3 mutations or fusions/rearrangements (PMID: 37956738; NCT02872714). 37956738