FDA approves Keytruda plus Padcev before and after surgery for cisplatin-eligible bladder cancer

The FDA approved Keytruda and Keytruda Qlex, each combined with Padcev, for adults with muscle-invasive bladder cancer who are eligible for cisplatin, given before cystectomy and continued after surgery. The approval rests on the Phase 3 KEYNOTE-B15 trial, which compared the regimen with gemcitabine plus cisplatin followed by surgery. It widens Keytruda's use in bladder cancer, a franchise that is still about half of Merck's revenue.

• KEYNOTE-B15 event-free survival hazard ratio 0.53 (95% CI 0.41-0.70)
• Overall survival hazard ratio 0.65 (95% CI 0.48-0.89)
• June EU approval covered cisplatin-ineligible patients only