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Molecular Profile | FGFR3 R248C |
Therapy | Erdafitinib |
Indication/Tumor Type | bladder urothelial carcinoma |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
FGFR3 R248C | bladder urothelial carcinoma | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines for patients with advanced bladder urothelial carcinoma who have received chemotherapy and an immune checkpoint inhibitor and harboring select FGFR mutations including FGFR3 R248C (PMID: 38490358; ESMO.org). | 38490358 detail... |
FGFR3 R248C | bladder urothelial 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 R248C 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... |