Merck’s Keytruda Gets FDA Nod for Platinum-Resistant Ovarian Cancer, Improves PFS 28%
FDA approves Merck’s Keytruda combination for PD-L1+ platinum-resistant ovarian, fallopian tube and peritoneal carcinoma after one or two prior regimens. Phase 3 KEYNOTE-B96 trial showed Keytruda plus paclitaxel with or without bevacizumab cut progression or death risk by 28% and improved median overall survival to 18.2 months versus 14.0 months.
1. FDA Expands Keytruda Indication
The FDA approved Keytruda and Keytruda Qlex in combination with paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian, fallopian tube, or peritoneal carcinoma after one or two prior systemic treatments, marking the first immunotherapy nod in this setting.
2. Clinical Trial Outcomes
Phase 3 KEYNOTE-B96 trial data showed Keytruda regimens reduced risk of disease progression or death by 28% and cut mortality risk by 24%. Patients with PD-L1 expression achieved a median progression-free survival of 8.3 months versus 7.2 months, and median overall survival of 18.2 months versus 14.0 months.
3. Commercial and Financial Impact
Keytruda generated $8.37 billion in global Q4 2025 sales, up 7% year-over-year, driven by earlier-stage approvals and metastatic demand. The new ovarian cancer indication could further bolster Merck’s oncology revenue and strengthen its competitive position against other PD-1 therapies.