FDA approves MSD’s Keytruda combinations for MIBC

The FDA has approved two of MSD's anti-PD-1 therapies, Keytruda and Keytruda Qlex, along with Padcev, for adults with MIBC. The decisions are based on findings from the Phase III KEYNOTE-B15 trial. KEYNOTE-B15 enrolled 808 patients and compared pembrolizumab plus enfortumab vedotin-ejfv with standard chemotherapy and surgery. Credit: Sai Thaw Kyar / Shutterstock.com. The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), for adults with muscle-invasive bladder cancer (MIBC). The new approvals for the anti-programmed death-1 (PD-1) therapies cover…

Salong Debbarma · 2026-07-13

The FDA has approved two of MSD's anti-PD-1 therapies, Keytruda and Keytruda Qlex, along with Padcev, for adults with MIBC.

Source: Pharmaceutical Technology