Merck, known as MSD outside the U.S. and Canada, has gained approval for Keytruda (pembrolizumab) in the European Union (EU). The approval is granted for use in combination with paclitaxel, and with or without bevacizumab.

This use of Keytruda is approved for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Their tumors must express PD-L1 with a Combined Positive Score (CPS) of greater than or equal to 1. Additionally, these patients must have received one to two prior systemic treatment regimens.

Keytruda Also Moved Forward in U.S.

The U.S. FDA approved Keytruda, in the same combination(s), for the same indications in February 2026.

The EU approval also covers Keytruda SC, the subcutaneous form of the treatment. This is known as Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.

A New Option in the EU

It is the first and only programmed death receptor-1 (PD-1) inhibitor-based treatment option for EU patients with platinum-resistant ovarian cancer.

Nicoletta Colombo, MD, PhD, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, weighed in.

“Patients … face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy,” Colombo said. “The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option.”

Merck Responds to Approval

Also reacting to this latest approval, Gursel Aktan, MD, PhD, Vice President of Global Clinical Development for Merck Research Laboratories.

“We’re proud to bring this Keytruda-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer,” Aktan said. “This milestone marks real progress for [women’s cancer patients] and advances our broader mission of expanding access to effective options.”

EU approval came following a Phase III trial (KEYNOTE-B96 or ENGOT-ov65). In this study, Keytruda plus the other aforementioned drugs demonstrated statistically significant, clinically meaningful improvement in progression-free survival.