# FDA Approves Pembrolizumab Plus Enfortumab Vedotin as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer

> fda · REPORTED · 2026-07-10

On July 10, 2026, the FDA approved pembrolizumab combined with enfortumab vedotin as neoadjuvant treatment followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer, one of four oncology approvals the agency cleared between July 10 and 24.

About Astellas / Pfizer (enfortumab vedotin plus pembrolizumab): The pembrolizumab plus enfortumab vedotin combination is a checkpoint inhibitor and antibody-drug conjugate regimen developed by Merck and Astellas/Pfizer for bladder cancer patients requiring surgical intervention.

- Company: Astellas / Pfizer (enfortumab vedotin plus pembrolizumab)
- Sector: oncology
- Primary source: https://lifesciencedaily.news/fda-drug-approval-decisions/

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.