A federal advisory panel meets Thursday to weigh a melanoma therapy for patients who have run out of standard options, and the agency's own briefing materials arrive with an unusually blunt framing: it is not clear the trial data can be interpreted.
The Cellular, Tissue, and Gene Therapies Advisory Committee will consider Biologics License Application 125827from Replimune for vusolimogene oderparepvec, known in development as RP1, in combination with nivolumab. The proposed indication is adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD-1-blocking antibody regimen.
