Replimune Group, Inc. announced on November 21, 2024, that it has submitted a Biologics License Application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab. The submission seeks accelerated approval for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.
Concurrently, the FDA granted Breakthrough Therapy designation to RP1 in combination with nivolumab for the same indication. This designation is intended to expedite the development and review of therapies for serious diseases where preliminary clinical evidence suggests substantial improvement over existing treatments.
The Breakthrough Therapy designation was based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. This marks an important milestone for Replimune and the melanoma community, moving the potential treatment closer to availability for patients with limited options.
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