Merck’s KEYTRUDA Approved In The European Union For Platinum-Resistant Ovarian Cancer

Merck announced that KEYTRUDA® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, has been approved in the European Union for patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer whose tumours express PD-L1 (CPS ≥1). This marks the first PD-1 inhibitor-based treatment option for this patient group in the EU.

The approval follows a positive opinion from the European Medicines Agency and is based on results from the Phase 3 KEYNOTE-B96 trial. The study demonstrated that the KEYTRUDA-based regimen significantly improved progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy regimens.

“Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy,” said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1-positive platinum-resistant ovarian cancer across Europe.”

In the trial, the combination reduced the risk of disease progression or death by 28% and the risk of death by 24% in eligible patients. Patients receiving KEYTRUDA experienced longer median survival than those on placebo-based regimens, reinforcing its clinical benefit in this difficult-to-treat population.

“We’re proud to bring this KEYTRUDA-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer, giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally.”

The approval applies across all EU member states and select European countries, though market availability will depend on local reimbursement processes. This follows a similar approval granted earlier in 2026 by the U.S. Food and Drug Administration, further expanding global access to the therapy.

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