North America Associated Press
Merck's KEYTRUDA and Padcev Gain EU Approval for Bladder Cancer Treatment After Surgery
Merck's KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) receives positive EU CHMP opinion for perioperative treatment in adults with muscle-invasive bladder cancer ineligible to receive cisplatin.
Merck announced a positive EU CHMP opinion for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer. This approval is based on results from the Phase 3 trial that showed significant overall survival benefits and improved outcomes compared to standard of care. The combination therapy has the potential to improve patient outcomes and quality of life for those with this type of cancer. Merck plans to submit a Biologics License Application (BLA) to the FDA following EU approval.
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