FDA approves erdafitinib for bladder cancer


  • Deepa Koli
  • Oncology drug update
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Takeaway

  • The FDA has granted accelerated approval to erdafitinib for patients with locally advanced or metastatic urothelial carcinoma, with susceptible fibroblast growth factor (FGFR) 3 or 2 genetic alterations, who have progressed on platinum-based chemotherapy.
  • Recommended initial dose is 8 mg orally once daily, which can be increased to 9 mg daily.
  • The FDA also approved companion diagnostic FGFR RGQ RT-PCR Kit for this therapeutic indication to identify patients suited for erdafitinib.

Why this matters

  • Erdafitinib is the first targeted therapy approved for advanced bladder cancer.

Key highlights

  • The approval was based on a multicenter, open-label, single-group study (BLC2001).
  • 87 patients with locally advanced or metastatic urothelial carcinoma who had progressed on prior chemotherapy and had FGFR2 or FGFR3 gene alterations received erdafitinib.
  • Objective response rate (primary efficacy outcome) was 32.2% (95% CI, 22.4%-42.0%) with:
    • complete responses, 2.3%;
    • partial responses, 29.9%; and
    • median response duration, 5.4 (95% CI, 4.2-6.9) months.
  • Erdafitinib can cause ocular disorders; 25% of patients experienced central serous retinopathy or retinal pigment epithelial detachment resulting in visual field defect.
  • Common adverse reactions (≥40%) were increased serum phosphate, stomatitis, fatigue, increased serum creatinine, diarrhea, dry mouth, onycholysis, increased alanine aminotransferase, increased alkaline phosphatase, and decreased sodium.

Prescribing Information, click here.

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