USFDAMay 29, 2026, 08:02 AM
Replimune Aligns with FDA on RP1 BLA Resubmission for Melanoma
AI Summary
Replimune Group, Inc. announced alignment with the U.S. Food and Drug Administration (FDA) on a path forward for the resubmission and reconsideration of the Biologics License Application (BLA) for RP1. The BLA is for RP1 in combination with nivolumab for the treatment of advanced melanoma. The company plans to resubmit the BLA in the coming days, with the FDA indicating it will prioritize the review due to the significant unmet need for patients.
Key Highlights
- Replimune and FDA aligned on path forward for resubmission of Biologics License Application (BLA) for RP1.
- Company will resubmit the RP1 BLA for advanced melanoma in the coming days.
- FDA will treat the BLA resubmission as an urgent matter and prioritize its review.
- RP1 is for advanced melanoma patients who progressed on prior anti-PD-1 based therapy.
- The BLA is supported by data from the IGNYTE clinical trial.
- Approximately 8,500 Americans with advanced melanoma die each year.
- Standard checkpoint inhibitor therapy fails approximately half of all patients.
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