RegulatoryApr 10, 2026, 05:03 PM
Replimune Receives FDA CRL for RP1 in Melanoma; Job Cuts Planned
AI Summary
Replimune Group, Inc. received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma. The company strongly disagrees with the FDA's decision, citing strong efficacy data (34% response rate, 24.8 months median duration) and a favorable safety profile. As a result, Replimune will eliminate jobs and scale back U.S. manufacturing, stating that the development of RP1 is no longer viable without timely accelerated approval.
Key Highlights
- RP1 plus nivolumab showed a 34% response rate in IGNYTE trial.
- Median duration of response was 24.8 months.
- Approximately 8,500 Americans with advanced melanoma die annually.
- Median progression-free survival on RP1 plus nivolumab was 30.6 months vs. 4.4 months on prior PD-1 regimen.