FDA Approval
The U.S. FDA has approved KEYTRUDA and KEYTRUDA QLEX for adults with PD-L1+ platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma. These approvals are based on the Phase 3 KEYNOTE-B96 trial results.
Trial Results
The KEYNOTE-B96 trial demonstrated that the KEYTRUDA regimen reduced the risk of disease progression or death by 28% and the risk of death by 24% compared to placebo plus paclitaxel, with or without bevacizumab. The trial results were presented at the 2025 European Society for Medical Oncology Congress.
Patient Impact
For patients with platinum-resistant ovarian cancer, the disease can limit treatment options. The FDA approvals offer new possibilities for patients who have been previously treated with standard platinum-based therapies.
Safety Information
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa. The treatments are associated with severe and potentially fatal immune-mediated adverse reactions, including pneumonitis, colitis, and hepatitis, among others.
