EU Approves KEYTRUDA Plus Paclitaxel for Platinum-Resistant Ovarian Cancer

The regimen is the first and only PD-1 inhibitor-based treatment option for eligible patients in the EU.

Apr. 2, 2026 at 1:06pm

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The European Commission has approved KEYTRUDA (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma who have received one or two prior systemic treatment regimens. This makes the KEYTRUDA regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU.

Why it matters

Ovarian cancer is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Prognosis is particularly poor for patients with platinum-resistant disease, and approved treatment options are limited.

The details

The approval is based on results from the Phase 3 KEYNOTE-B96 trial, in which the KEYTRUDA regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to placebo plus paclitaxel, with or without bevacizumab, for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1).

  • The European Commission approved the KEYTRUDA regimen in April 2026.
  • The U.S. FDA approved the KEYTRUDA regimen in February 2026.

The players

KEYTRUDA

An anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.

Merck

The pharmaceutical company that manufactures KEYTRUDA and sponsored the KEYNOTE-B96 trial.

Dr. Nicoletta Colombo

Director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy.

Dr. Gursel Aktan

Vice president, global clinical development, Merck Research Laboratories.

KEYNOTE-B96 trial

A Phase 3 clinical trial that evaluated KEYTRUDA plus paclitaxel, with or without bevacizumab, in patients with platinum-resistant recurrent ovarian cancer.

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What they’re saying

“Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy. 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.”

— Dr. Nicoletta Colombo, Director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy

“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. This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women's cancers globally.”

— Dr. Gursel Aktan, Vice president, global clinical development, Merck Research Laboratories

What’s next

The KEYTRUDA regimen will now become commercially available in EU countries as national reimbursement procedures are completed.

The takeaway

The approval of the KEYTRUDA-based regimen provides a much-needed new treatment option for patients with platinum-resistant ovarian cancer, a patient population with limited approved therapies and poor prognosis. This milestone represents progress in addressing the significant unmet medical need for effective treatments in women's cancers.