Global pharma powerhouse Merck has won European Union approval for its blockbuster immunotherapy KEYTRUDA (pembrolizumab), opening the door to a new treatment option for patients battling one of the most difficult forms of ovarian cancer.

 

The decision authorizes KEYTRUDA in combination with chemotherapy—paclitaxel, with or without bevacizumab—for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer whose tumors express PD-L1. Crucially, it marks the first and only PD-1 inhibitor-based regimen available in the EU for this patient group, signaling a shift in how the disease can be treated.

 

“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.”

 

The green light follows compelling results from the Phase 3 KEYNOTE-B96 trial, where the KEYTRUDA-based regimen significantly improved both progression-free survival and overall survival compared to standard chemotherapy alone. Patients receiving the therapy saw a 28% reduction in disease progression or death and a 24% reduction in risk of death—clear evidence of meaningful clinical benefit.

 

Median progression-free survival rose to 8.3 months from 7.2 months, while overall survival improved to 18.2 months versus 14.0 months with standard treatment.

 

“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 27 EU member states, as well as Iceland, Liechtenstein, and Norway, though rollout will depend on national reimbursement decisions.

 

It comes on the heels of a similar approval in the United States earlier this year, underscoring growing global momentum behind the therapy.

 

The stakes are high. Ovarian cancer remains one of the deadliest cancers among women worldwide, with more than 324,000 new cases and nearly 207,000 deaths reported in 2022. Most patients eventually relapse after first-line treatment, and those with platinum-resistant disease face particularly poor outcomes.