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Molecular Profile | FGFR3 S249C |
Therapy | Erdafitinib |
Indication/Tumor Type | transitional cell carcinoma |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
FGFR3 S249C | transitional cell carcinoma | sensitive | Erdafitinib | Phase III | Actionable | In a Phase III trial (THOR), Balversa (erdafitinib) therapy improved median overall survival (12.1 mo vs 7.8 mo HR=0.64, p=0.0005), median progression-free survival (5.6 mo vs 2.7 mo), and objective response rate (45.6% (62/135, 9 complete (CR), 53 partial responses (PR) vs 11.5% (15/130, 1 CR, 14 PR) compared to chemotherapy in metastatic urothelial carcinoma patients with alterations in FGFR3, including FGFR3 S249C (n=124), Y373C (n=45), R248C (n=25), G370C (n=13), and FGFR3-TACC3 (n=41) (PMID: 37870920). | 37870920 |
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... |
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... |
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... |
(37870920) | Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. | Full reference... |