# FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

Source: [What's New: Drugs RSS Feed](http://www.fda.gov/drugs/cancer-approvals/fda-approves-erdafitinib-locally-advanced-or-metastatic-urothelial-carcinoma) · 2026-11-07 · Medicine
Page: https://themorning.science/story/fda-approves-erdafitinib-for-locally-advanced-or-metastatic-urothelial-carcinoma-37929d719c518696
Kind: launch · Impact: medium

## In 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.

## Timeline

- 2024-01-19: FDA approves erdafitinib (Balversa) for locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alterations

## Coverage

- [FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma](http://www.fda.gov/drugs/cancer-approvals/fda-approves-erdafitinib-locally-advanced-or-metastatic-urothelial-carcinoma) — What's New: Drugs RSS Feed, 2026-11-07

Tags: oncology, fda, urothelial-carcinoma, fgfr3, drug-approval

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Brief generated by AI (claude-haiku-5-5) from the reporting listed under Coverage. Headlines belong to their publishers. The Morning Science – https://themorning.science