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# Keytruda Regimen for PD-L1–Positive Ovarian Cancers Approved
- URL: https://www.fdaweb.com/keytruda-regimen-for-pd-l1-positive-ovarian-cancers-approved/
- Published: 2026-02-11T12:00:00.000Z
- Updated: 2026-09-14T13:33:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160647

FDA has approved Merck’s Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with paclitaxel, with or without bevacizumab, for certain patients with platinum-resistant ovarian cancers. The approval covers adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 with a combined positive score (CPS) of at least 1, as determined by an FDA-authorized test, and who have received one or two prior systemic regimens. Alongside the drug approval, FDA cleared Agilent Technologies’ PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic to identify eligible patients based on PD-L1 expression.

The approval is based on data from KEYNOTE-B96 (NCT05116189), a randomized, double-blind, placebo-controlled Phase 3 trial enrolling 643 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or?ref=fdaweb.com). Eligible patients had received one or two prior lines of systemic therapy and had radiographic progression within six months after their last dose of platinum-based chemotherapy.

FDA says participants were randomized 1:1 to receive pembrolizumab plus paclitaxel, with or without bevacizumab, or placebo plus paclitaxel, with or without bevacizumab. The primary endpoint was progression-free survival (PFS) assessed by investigators under RECIST v1.1 criteria, with overall survival (OS) as a key secondary endpoint.

Among the 466 patients whose tumors expressed PD-L1, median PFS was 8.3 months in the pembrolizumab arm compared with 7.2 months in the control arm, FDA says. Median OS was 18.2 months with pembrolizumab versus 14.0 months with placebo.

FDA said the safety profile of pembrolizumab in combination with paclitaxel, with or without bevacizumab, was consistent with prior experience in other cancer indications. Labeling includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.