Replimune to Resubmit RP1 BLA for Advanced Melanoma in Third FDA Try with Urgent Review
REPL•Replimune will resubmit its RP1 biologics license application for advanced melanoma within days after FDA agreed to prioritize the review following collaborative discussions. This marks the company’s third FDA approval attempt, supported by IGNYTE trial data on RP1 plus nivolumab in patients progressing on anti-PD-1 therapy.
1. Path Forward for RP1 BLA Resubmission
Replimune and the FDA have aligned on resubmission of the RP1 BLA in coming days for use in combination with nivolumab to treat advanced melanoma. The agency will treat the application as urgent upon receipt, prioritizing review to address the unmet need in patients who progressed on anti-PD-1 therapies.
2. Third FDA Approval Attempt After Makary Exit
This resubmission represents Replimune’s third attempt at securing FDA approval for RP1, following the departure of regulatory lead Makary earlier this month. The timing underscores the company’s commitment to advancing its lead oncolytic immunotherapy despite recent leadership changes.
