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|Profile Name||FGFR3 fusion|
|Gene Variant Detail|
|Relevant Treatment Approaches|
|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FGFR3 fusion||Advanced Solid Tumor||predicted - sensitive||Futibatinib||Preclinical - Cell line xenograft||Actionable||In a preclinical study, Lytgobi (futibatinib) demonstrated growth inhibition and reduced FGFR phosphorylation in human cancer cell lines and xenograft models harboring FGFR mutations (Mol Cancer Ther 2013;12(11 Suppl):A270).||detail...|
|FGFR3 fusion||transitional cell carcinoma||sensitive||Infigratinib||Phase I||Actionable||In a Phase I trial, Truseltiq (infigratinib) treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517)).||detail...|
|FGFR3 fusion||urinary bladder cancer||sensitive||AZD4547||Preclinical - Cell culture||Actionable||In a preclinical study, AZD4547 inhibited survival of bladder cancer cells harboring FGFR3 fusion in culture (PMID: 27550940).||27550940|
|FGFR3 fusion||transitional cell carcinoma||predicted - sensitive||Docetaxel + Vofatamab||Phase Ib/II||Actionable||In a Phase I/II trial, Vofatamab (B-701) in combination with Taxotere (docetaxel) demonstrated safety and preliminary efficacy, resulted in enhanced activity in patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 mutations or fusions comparing to wild-type patients (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 4534-4534; NCT02401542).||detail...|
|FGFR3 fusion||Advanced Solid Tumor||predicted - sensitive||Debio 1347||Phase I||Actionable||In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297).||30745300|
|FGFR3 fusion||transitional cell carcinoma||predicted - sensitive||Erdafitinib||Phase I||Actionable||In a Phase I trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 46% (12/26) in patients with urothelial carcinoma harboring FGFR genomic alterations, including 17 with FGFR3 mutations, and 11 with FGFR2 and/or FGFR3 fusions (PMID: 31088831; NCT01703481).||31088831|
|FGFR3 fusion||urinary bladder cancer||sensitive||Regorafenib||Preclinical - Cell culture||Actionable||In a preclinical study, bladder cancer cell lines harboring an FGFR3 fusion were sensitive to treatment with Stivarga (regorafenib), demonstrating inhibition of cell growth (PMID: 33563752).||33563752|
|FGFR3 fusion||bladder urothelial carcinoma||sensitive||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 fusion||Advanced Solid Tumor||predicted - sensitive||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 fusion||transitional cell carcinoma||sensitive||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|