---
title: "FDA approves Pfizer PADCEV-Keytruda combo for perioperative muscle-invasive bladder cancer"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/292338259.md"
description: "The FDA has approved the combination of Pfizer's PADCEV and Keytruda for the perioperative treatment of adult muscle-invasive bladder cancer, regardless of cisplatin eligibility. This approval, based on EV-304 trial data showing improved event-free and overall survival rates, establishes the first FDA-cleared platinum-free regimen for this condition. Astellas co-developed PADCEV."
datetime: "2026-07-10T15:23:43.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/292338259.md)
  - [en](https://longbridge.com/en/news/292338259.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/292338259.md)
---

# FDA approves Pfizer PADCEV-Keytruda combo for perioperative muscle-invasive bladder cancer

-   FDA cleared PADCEV with Keytruda for neoadjuvant, adjuvant treatment of adult muscle-invasive bladder cancer, regardless of cisplatin eligibility. \* EV-304 data showed improved event-free survival versus gemcitabine-cisplatin, hazard ratio 0.53; 2-year event-free rate 79.4% versus 66.2%. \* Overall survival improved, hazard ratio 0.65; pathological complete response reached 55.8% versus 32.5% at surgery. \* Astellas co-develops PADCEV; approval establishes the first FDA-cleared platinum-free perioperative regimen for muscle-invasive bladder cancer. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Pfizer Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260710224617) on July 10, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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