Keytruda + paclitaxel PDUFA Date (Merck)

Name: FDA PDUFA Decision: Keytruda + paclitaxel
Start: 2026-02-10

FDA PDUFA decision date for Keytruda + paclitaxel is February 10, 2026. Developed by Merck. Indication: Platinum-resistant recurrent ovarian cancer (PD-L1+). Current status: Approved.

Indication

Platinum-resistant recurrent ovarian cancer (PD-L1+)

Regulatory details

Company: Merck
Therapeutic area: Oncology
Application type: sBLA
Review type: Priority
PDUFA date: 2026-02-10
Outcome: Approved

Keytruda + paclitaxel PDUFA Date — Merck