FDA approves Merck's Keytruda for ovarian cancer treatment

LootboxPhobia · 2026-02-14T11:23:35+00:00

The US FDA has approved Merck's pembrolizumab and pembrolizumab in combination for the treatment of certain ovarian cancer patients, based on clinical trial results showing its efficacy superior to placebo. The approval also includes companion diagnostic testing to identify eligible patients.

LootboxPhobia

2026-02-14 11:23:35

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Investing.com – The U.S. Food and Drug Administration (FDA) has approved Merck’s pembrolizumab (Keytruda) and pembrolizumab in combination with BLA-HA enzyme alfa-pmph (Keytruda Qlex) for the treatment of certain ovarian cancer patients.

The approval announced on Tuesday applies to adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose tumors express PD-L1 (CPS ≥1) and who have received one or two systemic treatment regimens.

The FDA also approved Agilent Technologies’ PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify eligible patients.

This approval is based on the results of the KEYNOTE-B96 trial, which involved 643 patients with platinum-resistant ovarian cancer. Among 466 patients whose tumors expressed PD-L1, those treated with Keytruda plus paclitaxel (with or without bevacizumab) showed better outcomes compared to those receiving placebo plus the same combination therapy.

The median progression-free survival for the Keytruda group was 8.3 months, compared to 7.2 months for the placebo group. The median overall survival reached 18.2 months in the Keytruda group versus 14.0 months in the placebo group.

The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks. For Keytruda Qlex, the recommended dose is 395 mg/4,800 units every three weeks or 790 mg/9,600 units every six weeks. Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 months.

This review was conducted under the “Project Orbis,” an FDA initiative that allows international partners—including Australia, Canada, and Switzerland—to submit and review oncology drugs simultaneously. The application has been granted priority review.

Prescribing information includes warnings about immune-mediated adverse reactions, infusion-related reactions, allogeneic hematopoietic stem cell transplant complications, and embryofetal toxicity.

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