- EU approval granted April 2, 2026 after a CHMP positive recommendation in February 2026.
- Phase 3 KEYNOTE-B96 (ENGOT-ov65) showed pembrolizumab + paclitaxel ± bevacizumab significantly improved progression-free and overall survival versus placebo + paclitaxel ± bevacizumab.
- Indication: adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1 CPS ≥1 who received one or two prior systemic regimens.
- Regimen components: pembrolizumab (KEYTRUDA), paclitaxel, optional bevacizumab; approval also covers subcutaneous KEYTRUDA SC (pembrolizumab + berahyaluronidase alfa-pmph).
Approval and indication
On April 2, 2026 Merck announced European Commission approval of pembrolizumab (KEYTRUDA) plus paclitaxel, with or without bevacizumab, for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD‑L1 (CPS ≥1) after one or two prior systemic regimens; the approval includes KEYTRUDA SC (pembrolizumab with berahyaluronidase alfa‑pmph).
Clinical evidence
The decision was supported by Phase 3 KEYNOTE‑B96 (ENGOT‑ov65), in which pembrolizumab plus paclitaxel ± bevacizumab demonstrated a statistically significant improvement in progression‑free survival (primary endpoint) and overall survival (key secondary endpoint) versus placebo plus paclitaxel ± bevacizumab in patients with PD‑L1 CPS ≥1 tumors.
Regulatory context
The approval follows a positive recommendation from the European Medicines Agency’s CHMP in February 2026 and establishes this regimen as the first PD‑1 inhibitor‑based treatment option for eligible platinum‑resistant ovarian cancer patients in the EU.
Regimen components
Active substances cited are pembrolizumab (intravenous and subcutaneous formulations), paclitaxel and bevacizumab; the subcutaneous formulation is pembrolizumab combined with berahyaluronidase alfa‑pmph.
