MSD has received the US Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), along with paclitaxel, with or without bevacizumab, for ovarian cancer.
The therapies are approved as second or third-line treatment for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express programmed death-ligand 1 (PD-L1) (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorised test.
The approvals stem from the Phase III KEYNOTE-B96 trial (ENGOT-ov65) data, which was presented at the 2025 European Society for Medical Oncology (ESMO) Congress. Results demonstrated statistically significant improvements in progression-free survival and overall survival compared to placebo plus paclitaxel with or without bevacizumab for patients whose tumours express PD-L1 (CPS ≥1).
The approval of Keytruda Qlex for its indications is supported by data from well-controlled studies of Keytruda and additional results from MK-3475A-D77, which compared the efficacy, safety, and pharmacokinetic profiles of Keytruda Qlex and Keytruda.
This approval reinforces MSD's commitment to advancing innovative therapies and improved outcomes across women’s cancers. Previously, in June 2025, MSD received FDA approval for its anti-PD-1 therapy, Keytruda, for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
