FDA Accepts Replimune RP1 BLA Resubmission

The United States — Food and Drug Administration has accepted the resubmission of Replimune Group's Biologics License Application (BLA) for RP1, an oncolytic immunotherapy, in combination with nivolumab for the treatment of advanced melanoma. The United States — Food and Drug Administration has designated this as a complete, class 1 response, with a target action date of August 2, 2026, and an advisory committee meeting anticipated in late July. This resubmission seeks accelerated approval for RP1 based on data from the IGNYTE clinical trial, which evaluated the therapy in patients with advanced melanoma who had progressed on an anti-PD-1 regimen. Sushil Patel, CEO of Replimune Group, expressed optimism regarding the United States — Food and Drug Administration's expedited review, emphasizing the critical need for new treatments for advanced melanoma patients.