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

(RTTNews) - 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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