Merck & Co. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab + berahyaluronidase alfa-pmph) in combination with paclitaxel (± bevacizumab) for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in PD-L1+ (CPS ≥1) adults who have received 1-2 prior systemic regimens. The approval, based on Phase III KEYNOTE-B96 data, marks Keytruda’s entry into platinum-resistant ovarian cancer—a high-unmet-need setting with limited effective options.
EMA, PMDA, NMPA submissions for platinum-resistant ovarian cancer
2026-2027
Combination Optimization
Explore Keytruda + PARP inhibitors (niraparib) or anti-angiogenics in earlier lines
Investigational
Biomarker Refinement
CPS ≥10 subset analysis for enhanced efficacy population
Post-approval
Forward‑Looking Statements This brief contains forward‑looking statements regarding Keytruda commercial performance in platinum-resistant ovarian cancer, global regulatory expansion, and competitive dynamics with mirvetuximab soravtansine. Actual results may differ due to reimbursement negotiations, PD-L1 testing adoption rates, and physician preference for chemotherapy-backbone vs. targeted therapy approaches.-Fineline Info & Tech
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