FDA panel backs melanoma therapy after 2 rejections

An FDA advisory committee voted 10-3 July 30 that efficacy results from Replimune’s study for RP1 were evaluable and clinically meaningful, advancing the company’s application for the experimental melanoma therapy after the FDA rejected it twice. The Cellular, Tissue, and Gene Therapies Advisory Committee reviewed Replimune’s biologics license application resubmission for RP1 (vusolimogene oderparepvec) in […] The post FDA panel backs melanoma therapy after 2 rejections a...