Replimune BLA for RP1+nivolumab in advanced melanoma accepted with Priority Review; PDUFA July 22, 2025

Replimune Group, Inc.

FDA accepted BLA for RP1 (vusolimogene oderparepvec) plus nivolumab for advanced melanoma; granted Priority Review.
PDUFA action date set for July 22, 2025; no advisory committee meeting currently planned.
BLA supported by primary analysis from IGNYTE trial in anti-PD-1 failed melanoma patients.
Confirmatory Phase 3 IGNYTE-3 trial ongoing with over 100 planned sites globally.
Replimune previously received Breakthrough Therapy designation for this combination.

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