USFDAJul 30, 2026, 08:13 AM
Replimune to Discuss RP1 BLA Resubmission with FDA Advisory Cmte
AI Summary
Replimune Group, Inc. is scheduled to meet with the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026. The meeting will discuss the company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The company presented strong efficacy data from the IGNYTE study, showing an ORR of 33.6% and a median DoR of 24.8 months, alongside a favorable safety profile. An initial FDA clinical review in 2025 had already recommended accelerated approval for RP1.
Key Highlights
- Replimune to meet with FDA Advisory Committee on July 30, 2026, for RP1 BLA resubmission.
- RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma.
- IGNYTE study showed Objective Response Rate (ORR) of 33.6% (95% CI: 25.8, 42.0).
- Median Duration of Response (DoR) was 24.8 months (95% CI: 14.1, NE).
- 3-year Overall Survival (OS) rate was 47.8%, with median OS of 32.9 months.
- Safety profile was well-tolerated, with mainly Grade 1 and 2 adverse events.
- Initial FDA clinical review on July 15, 2025, recommended accelerated approval for RP1.
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