Merck’s Keytruda–Padcev regimen advances toward broader European use

Merck ($MRK) received a positive European advisory opinion for Keytruda combined with Padcev before and after radical cystectomy in adults with resectable muscle-invasive bladder cancer. The recommendation also covers subcutaneous Keytruda. It would broaden the existing European indication beyond patients unable to receive cisplatin-based chemotherapy, but still requires a European Commission decision.

The supporting KEYNOTE-B15 study enrolled cisplatin-eligible patients and showed a 47% reduction in the risk of progression, recurrence or death versus preoperative chemotherapy and surgery. The risk of death was reduced by 35%. These comparative trial results underpin the proposed expansion; they are not guarantees for individual patients. A final regulatory decision is expected in the fourth quarter. The company is US-listed Merck & Co., not Germany’s Merck KGaA.

Sources:

• Merck — CHMP opinion and KEYNOTE-B15 evidence, Business Wire