MRK · News · 20260921N

Regulatory Approval Milestones

Merck & Co., Inc. · 2026-09-21 · Importance 38 · Surprise 60

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) backed Merck’s KEYTRUDA plus Padcev combination as a perioperative treatment for eligible patients with resectable muscle-invasive bladder cancer. The recommendation concerns treatment around surgery and applies to patients meeting the specified resectable disease criteria. The digest does not state the expected European Commission decision date, pricing, or projected revenue impact.

Key facts

• The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use for all indications approved in Japan for KEYTRUDA® (pembrolizumab). source
• Merck's Keytruda plus Padcev combo received CHMP backing as perioperative treatment for eligible patients with resectable muscle-invasive bladder cancer. source