{"id":62392,"date":"2026-04-04T21:55:09","date_gmt":"2026-04-04T13:55:09","guid":{"rendered":"https:\/\/flcube.com\/?p=62392"},"modified":"2026-04-04T21:55:11","modified_gmt":"2026-04-04T13:55:11","slug":"mercks-keytruda-receives-eu-approval-for-platinum-resistant-ovarian-cancer-in-combination-regimen","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=62392","title":{"rendered":"Merck’s KEYTRUDA Receives EU Approval for Platinum-Resistant Ovarian Cancer in Combination Regimen"},"content":{"rendered":"\n

Merck & Co., Inc.<\/strong> (MSD, NYSE: MRK<\/a>) announced that the European Commission<\/strong> has granted marketing authorization for KEYTRUDA<\/strong> (pembrolizumab) in combination with paclitaxel<\/strong>, with or without bevacizumab<\/strong>, for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma<\/strong> in adults whose tumors express PD-L1<\/strong> with a Combined Positive Score (CPS) \u22651<\/strong> and who have received one or two prior systemic treatment regimens.<\/p>\n\n\n\n

Regulatory Approval Details<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Merck & Co., Inc. (MSD)<\/td><\/tr>
Stock Code<\/strong><\/td>NYSE: MRK<\/td><\/tr>
Approved Product<\/strong><\/td>KEYTRUDA (pembrolizumab)<\/td><\/tr>
Formulations<\/strong><\/td>Intravenous and subcutaneous (KEYTRUDA SC\/KEYTRUDA QLEXTM)<\/td><\/tr>
Indication<\/strong><\/td>Platinum-resistant ovarian cancer (epithelial ovarian, fallopian tube, primary peritoneal)<\/td><\/tr>
Patient Population<\/strong><\/td>PD-L1 CPS \u22651, 1-2 prior systemic treatments<\/td><\/tr>
Regulatory Body<\/strong><\/td>European Commission<\/td><\/tr>
CHMP Recommendation<\/strong><\/td>February 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 Phase 3 KEYNOTE-B96 Trial<\/h2>\n\n\n\n
Endpoint<\/th>KEYTRUDA + Paclitaxel \u00b1 Bevacizumab<\/th>Placebo + Paclitaxel \u00b1 Bevacizumab<\/th>Statistical Significance<\/th><\/tr><\/thead>
Progression-Free Survival (PFS)<\/strong><\/td>Primary endpoint met<\/td>Control arm<\/td>Statistically significant improvement<\/td><\/tr>
Overall Survival (OS)<\/strong><\/td>Key secondary endpoint<\/td>Control arm<\/td>Clinically meaningful improvement<\/td><\/tr>
Trial Designation<\/strong><\/td>KEYNOTE-B96 \/ ENGOT-ov65<\/td>Phase 3 randomized controlled trial<\/td>Global multi-center study<\/td><\/tr>
Patient Population<\/strong><\/td>Platinum-resistant recurrent ovarian cancer, PD-L1 CPS \u22651<\/td>Same criteria<\/td>Biomarker-selected population<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The approval represents a landmark achievement as this regimen becomes the first and only PD-1 inhibitor-based treatment option<\/strong> for eligible patients with platinum-resistant ovarian cancer in the European Union.<\/p>\n\n\n\n

Market Impact & Therapeutic Significance<\/h2>\n\n\n\n