Twice-Rejected Melanoma Drug Gets Love From FDA Panel
(MedPage Today) -- In the wake of a surprise FDA advisory committee vote on Thursday, the third time could be the charm for RP1 (vusolimogene oderparepvec), a melanoma drug candidate that's already been rejected twice by the agency. Despite doubts...
The FDA advisory committee has given a vote of confidence to RP1, a melanoma drug candidate that has been rejected twice by the agency. Despite skepticism from reviewers, the Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 in favor of the phase II IGNYTE study, which tested RP1 combined with nivolumab. The study showed promising results, with 33.6% of patients responding to the treatment, including complete responses in 16.4%.
The drugmaker, Replimune, is seeking accelerated approval based on these findings, which were gathered from patients with advanced melanoma who had already progressed on anti-PD-1 therapy.
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