MSD Secures European Approval for Keytruda Combination Therapy in Ovarian Cancer
- nuaxia
- 6 days ago
- 1 min read
Keytruda now approved across EU for PD-L1-positive platinum-resistant ovarian, fallopian tube, and primary peritoneal carcinoma.
Merck’s Keytruda, combined with paclitaxel with or without bevacizumab, has received European Commission approval for adults with PD-L1-positive platinum-resistant ovarian cancer, following positive Phase III KEYNOTE-B96 trial results showing improved progression-free and overall survival.
The approval also covers Keytruda SC (Keytruda Qlex in the US), providing Europe’s first PD-1 inhibitor-based treatment option for this patient population.
Alert Type | European Commission Approval |
Drug/Device Name | Keytruda (pembrolizumab) ± paclitaxel ± bevacizumab; Keytruda SC (Keytruda Qlex in US) |
Indication | PD-L1-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma |
Therapy Area(s) | Oncology, Gynecologic Oncology, Immunotherapy |
Geography | European Union (27 member states), Norway, Iceland, Liechtenstein |
What Changed | The EC approved Keytruda combination therapy for adults with PD-L1-positive platinum-resistant ovarian cancer following positive Phase III KEYNOTE-B96 trial results showing improved progression-free and overall survival. Approval includes Keytruda SC (Keytruda Qlex in the US). |
Clinical Relevance | Provides the first PD-1 inhibitor-based treatment option for this patient population in Europe, expanding access and offering a clinically meaningful survival benefit for PD-L1-positive platinum-resistant ovarian cancer patients. |
Source Link | |
Date | 1-Apr-2026 |
Status | Draft |
Notes | Approval follows FDA approval in Feb 2026; based on Phase III KEYNOTE-B96 (ENGOT-ov65); includes adults who had 1–2 prior systemic regimens. |
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