FDA approves Merck's KEYTRUDA and KEYTRUDA QLEX for ovarian cancer

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KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant O

February 11, 2026 6:45 AM EST

KEYTRUDA and KEYTRUDA QLEX are the first and only PD-1 inhibitors approved for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1+ tumors

Approvals based on Phase 3 KEYNOTE-B96 trial that demonstrated the KEYTRUDA regimen reduced the risk of disease progression or death by 28% and reduced the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food... More