Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA
Replimune announced it will resubmit its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma in the coming days. Following collaborative discussions, the FDA has agreed to treat the resubmission as an urgent matter and prioritize its review, acknowledging the significant unmet need in the advanced melanoma community.
Key figures
- Drug Name
- RP1 (vusolimogene oderparepvec)
- Melanoma new cases 2026
- 112000
- Melanoma deaths annually
- 8500
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