USFDAApr 13, 2026, 06:06 AM
Replimune Receives Second FDA CRL for RP1 BLA in Melanoma
AI Summary
Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a second Complete Response Letter regarding its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec). The BLA sought approval for RP1 in combination with nivolumab for the treatment of advanced melanoma. This second CRL indicates further hurdles for the company in bringing this treatment to market.
Key Highlights
- Replimune Group received a second Complete Response Letter (CRL) from the FDA.
- The CRL pertains to the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec).
- RP1 was submitted in combination with nivolumab for advanced melanoma treatment.