Replimune submits BLA for RP1+nivolumab in advanced melanoma under Accelerated Approval; FDA grants Breakthrough Therapy

Replimune Group, Inc.

BLA submitted to FDA for RP1 (vusolimogene oderparepvec) + nivolumab in advanced melanoma patients previously treated with anti-PD1.
Submission under Accelerated Approval pathway; based on safety and activity in IGNYTE trial.
FDA granted Breakthrough Therapy designation for RP1 + nivolumab in same setting.
Confirmatory Phase 3 IGNYTE-3 trial enrolling patients with prior anti-PD1 and anti-CTLA-4 therapy.

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