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news.Merck (MSD) has received the European Commission (EC) approval for Keytruda (pembrolizumab) along with paclitaxel, with or without bevacizumab, as a treatment for programmed death-ligand 1 (PD-L1)-positive ovarian cancer.
The authorisation is based on results from the Phase III KEYNOTE-B96 trial, also known as ENGOT-ov65. Credit: Asian Isolated/Shutterstock.com.
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The approval in the European Union (EU) is for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours are PD-L1 positive, with a combined positive score of one or more, and who have previously undergone one or two systemic treatment regimens.
It also covers Keytruda SC, known in the US as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph).
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February 2026.
The authorisation is based on results from the Phase III KEYNOTE-B96 trial, also known as ENGOT-ov65.
In the study, Keytruda plus paclitaxel, with or without bevacizumab, showed a statistically significant and clinically meaningful improvement in progression-free survival, the primary endpoint, versus placebo plus paclitaxel, with or without bevacizumab.
It also improved overall survival, a key secondary endpoint, in patients with platinum-resistant recurrent ovarian cancer whose tumours expressed PD-L1 with a Combined Positive Score [CPS] of at least one.
Merck Research Laboratories global clinical development vice-president Dr Gursel Aktan said: “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.”
The approval covers all 27 EU member states, plus Norway, Iceland and Liechtenstein.
In February 2026, the US Food and Drug Administration (FDA) approved the same regimen in the US for the same adult patient population.
