FDA approves Merck's (MRK) Keytruda for platinum-resistant ovarian cancer patients

The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma on February 10, 2026.

The approval applies to patients whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test and who have received one or two prior systemic treatment regimens. The treatment may be used with or without bevacizumab.

The FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients whose tumors express PD-L1 for treatment with pembrolizumab.

The approval was based on results from KEYNOTE-B96, a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 643 patients with platinum-resistant ovarian cancer who had received one or two prior lines of systemic therapy.

Among 466 patients with tumors expressing PD-L1 with CPS ≥ 1, median progression-free survival was 8.3 months in the pembrolizumab arm compared to 7.2 months in the placebo arm. Median overall survival was 18.2 months in the pembrolizumab arm and 14.0 months in the placebo arm.

The recommended dose of pembrolizumab is 200 mg every three weeks or 400 mg every six weeks until disease progression, unacceptable toxicity, or up to 24 months. For pembrolizumab and berahyaluronidase alfa-pmph, the recommended dose is 395mg/4,800 units every three weeks or 790mg/9,600 units every six weeks.

The review was conducted under Project Orbis, with FDA collaborating with Australia's Therapeutic Goods Administration, Health Canada, and Switzerland's Swissmedic. The application was granted priority review status.

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