RP1 (vusolimogene oderparepvec) PDUFA Date (Replimune Group)
FDA PDUFA decision date for RP1 (vusolimogene oderparepvec) is April 10, 2026. Developed by Replimune Group. Indication: Advanced melanoma (anti-PD-1 failed). Current status: Verifying.
Indication
Advanced melanoma (anti-PD-1 failed)
Notes
Resubmitted BLA. Oncolytic immunotherapy for melanoma.
Regulatory details
- Company: Replimune Group
- Therapeutic area: Oncology
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-04-10
- Outcome: Pending