An FDA advisory panel voted 10 to 3 on Thursday that the key trial data behind an experimental melanoma treatment are evaluable and clinically meaningful, siding with the manufacturer over the agency's own scientific reviewers. The FDA is scheduled to decide whether to approve the product by Monday.
The Cellular, Tissue, and Gene Therapies Advisory Committee reviewed Biologics License Application 125827 from Replimune for vusolimogene oderparepvec, known as RP1, given in combination with nivolumab. The proposed use is for adults with advanced melanoma who have already progressed on a regimen containing an anti-PD-1 drug.
