The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for previously treated ovarian cancer patients.

In September 2025, the FDA approved Keytruda Qlex injection for subcutaneous administration in adults across most solid tumor indications for Keytruda.

Wednesday’s approval covers adults with PD-L1+ platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.

These approvals are based on data from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65).

Trial Data

Results from the trial showed that Keytruda plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant ...