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FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

What's New: Drugs RSS Feed · By FDA ·

The Brief

  • The FDA approved erdafitinib (Balversa, Janssen Biotech) on January 19, 2024.
  • The approval covers locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations.
  • The approval applies to disease that progressed on or after at least one line of prior therapy.

Why it matters

Patients with susceptible FGFR3 genetic alterations and advanced urothelial carcinoma now have an FDA-approved targeted drug option after prior treatment.

Who’s affected

  • Patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior…

Timeline

  1. FDA approves erdafitinib (Balversa) for locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alterations

  2. What's New: Drugs RSS Feed

    FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

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