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Molecular Profile FGFR3 S249C
Therapy Erdafitinib
Indication/Tumor Type transitional cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 S249C transitional cell carcinoma sensitive Erdafitinib Guideline Actionable Balversa (erdafitinib) is included in guidelines for patients with advanced urothelial carcinoma who have received chemotherapy and an immune checkpoint inhibitor and harboring select FGFR mutations including FGFR3 S249C (PMID: 38490358; ESMO.org). 38490358 detail...
FGFR3 S249C transitional cell carcinoma sensitive Erdafitinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (BCL2001) that supported FDA approval, Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 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 (PMID: 31340094; NCT02365597). detail... 31340094 detail...
PubMed Id Reference Title Details
ESMO Clinical Practice Guidelines Full reference...
Full reference...
Balversa (erdafitinib) FDA Drug Label Full reference...
(31340094) Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. Full reference...
(38490358) ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma. Full reference...