# FDA Approves Padcev Plus Keytruda for Muscle-Invasive Bladder Cancer

> fda · REPORTED · 2026-07-07

The FDA approved the combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, expanding a regimen that had already shown strong results in metastatic disease. The approval marks a significant new standard-of-care option for earlier-stage bladder cancer patients.

About Pfizer / Merck / Astellas: Pfizer and Astellas co-commercialize Padcev, a first-in-class antibody-drug conjugate targeting Nectin-4, in combination with Merck's Keytruda checkpoint inhibitor, together forming a leading immuno-oncology combination for urothelial cancers.

- Company: Pfizer / Merck / Astellas
- Sector: therapeutics
- Primary source: https://www.thepharmaletter.com/news

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