Merck's KEYTRUDA Receives Positive Opinion From EU CHMP for Bladder Cancer Treatment

Merck & Co. Inc. (MRK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of KEYTRUDA in combination with Padcev for the neoadjuvant treatment of adults with resectable muscle-invasive bladder cancer.

The recommendation specifically targets patients with high-risk, locally advanced, or resectable muscle-invasive bladder cancer. The combination therapy is intended to be administered prior to surgical removal of the tumor, a process known as cystectomy.

KEYTRUDA is Merck’s anti-PD-1 therapy. Padcev is a separate therapy. The CHMP opinion is a significant step in the regulatory process within the European Union.