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 improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 28%
In this same population, the Keytruda regimen also demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab.
In patients whose tumors express PD-L1 (CPS ≥1), the median PFS was 8.3 months for those receiving Keytruda plus paclitaxel, with or without bevacizumab, versus 7.2 months for those receiving placebo plus paclitaxel with or without bevacizumab.
The median OS for these patients receiving the Keytruda regimen was 18.2 months (95% CI, 15.3-21.0) versus 14.0 months (95% CI, 12.5-16.1) for those receiving the placebo regimen.
Why It Matters
Keytruda generated $8.37 billion in global sales in the fourth quarter of 2025, representing a 7% year-over-year increase. Growth driven by strong global uptake in earlier-stage indications, as well as continued global demand in metastatic indications.
In June 2025, the FDA approved Keytruda for resectable locally advanced head and neck squamous cell carcinoma patients whose tumors express PD-L1, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin, and then as a single agent.
MRK Price Action: Merck & Co shares were up 0.22% at $117.00 at the time of publication on Wednesday, according to Benzinga Pro data.
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