India Pharma Outlook Team | Monday, 24 November 2025
Merck has secured a major win today as the US FDA approved KEYTRUDA and KEYTRUDA QLEX, used with Padcev, for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin.
This marks the first time a PD-1 inhibitor has been cleared in combination with an antibody-drug conjugate for this group, opening a new path where options have long been limited.
The approval is built on findings from the Phase 3 KEYNOTE-905 (EV-303) trial, run with Pfizer and Astellas. The data is striking. Patients on the KEYTRUDA–Padcev regimen saw a 60 percent drop in the risk of event-free survival events compared with surgery alone. Overall survival improved by 50 percent. And 57 percent reached a pathologic complete response, far ahead of the 9 percent seen with surgery alone.
Also Read: Advanced Formulation Technologies Streamlining Global Pharma Innovation
“These approvals could be practice-changing for patients who previously had no options beyond surgery,” said Dr Matthew Galsky, KEYNOTE-905 study investigator at Mount Sinai Tisch Cancer Center. “Half of MIBC patients face cancer recurrence even after bladder removal, and many cannot receive cisplatin. This therapy offers hope where there was none.”
Merck emphasizes flexibility in administration, allowing patients to receive immunotherapy intravenously or subcutaneously. “Our commitment to patients drives innovation,” said Dr Marjorie Green, senior VP, Merck Research Laboratories. “We are proud to provide new, life-saving options for those in need.”
Merck highlights that treatment can be given intravenously or subcutaneously, giving clinics more flexibility. The company also notes the need for close monitoring, as KEYTRUDA and Padcev can trigger serious immune-mediated reactions, infusion issues, and fetal risks during pregnancy.
The KEYNOTE-905 trial enrolled 344 cisplatin-ineligible patients. Participants received three cycles before surgery, then up to 14 cycles of adjuvant KEYTRUDA and six of Padcev.
