---
title: "Health Canada Approves Merck's Keytruda With Enfortumab Vedotin For Bladder Cancer"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/294992831.md"
description: "Health Canada has approved Merck's Keytruda in combination with enfortumab vedotin for adults with muscle-invasive bladder cancer ineligible for cisplatin-based chemotherapy. This approval, based on the Phase 3 KEYNOTE-905 trial conducted with Pfizer and Astellas, allows Keytruda to be used as neoadjuvant treatment followed by surgery and adjuvant therapy. The combination demonstrated significant improvements in event-free survival, overall survival, and pathological complete response rates compared to surgery alone."
datetime: "2026-08-05T16:25:20.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/294992831.md)
  - [en](https://longbridge.com/en/news/294992831.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/294992831.md)
generator: "portal-rs"
---

# Health Canada Approves Merck's Keytruda With Enfortumab Vedotin For Bladder Cancer

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Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, said on Wednesday that Health Canada approved its cancer drug Keytruda in combination with enfortumab vedotin for certain adults with muscle-invasive bladder cancer.

The approval covers patients who are ineligible for cisplatin-containing chemotherapy. Keytruda will be used as neoadjuvant treatment, followed by radical cystectomy, and then continued as adjuvant treatment after surgery.

Keytruda, or pembrolizumab, is Merck's anti-PD-1 therapy. Enfortumab vedotin is an antibody-drug conjugate. The approval was based on data from the Phase 3 KEYNOTE-905 trial, also known as EV-303. 

The trial was conducted with Pfizer Inc. (PFE) and Astellas Pharma Inc. (ALPMF). It showed a statistically significant improvement in event-free survival and overall survival for patients treated with the combination versus radical cystectomy and pelvic lymph node dissection alone. It also showed a statistically significant difference in pathological complete response rate.

"Muscle-invasive bladder cancer can have a significant impact on patients and their families, particularly for those who are not candidates for cisplatin-based chemotherapy," said Michelle Colero, Executive Director at Bladder Cancer Canada. 

On the NYSE, shares of Merck & Co are currently gaining 1.22 percent, changing hands at $129.56. 

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