Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
FDA approved pembrolizumab with paclitaxel, with or without bevacizumab, for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with PD-L1 CPS ≥1, based on KEYNOTE-B96 trial results.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
The FDA approved pembrolizumab in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1).
Merck secures regulatory approvals for Keytruda in ovarian cancer and subcutaneous formulation in Canada, while launching AI-driven drug discovery partnership with Mayo Clinic targeting high-need therapeutic areas.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
The FDA approved pembrolizumab plus paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian cancer based on phase 3 KEYNOTE-B96 trial results showing improved survival outcomes.
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.