FDA panel supports Replimune’s RP1 melanoma data after two regulatory rejections
A United States Food and Drug Administration (FDA) advisory committee has voted 10 to 3 that efficacy findings from Replimune Group’s IGNYTE study of RP1 plus nivolumab are evaluable and clinically meaningful, handing the experimental melanoma treatment a significant regulatory reprieve after two earlier rejection letters. The committee considered RP1, also known as vusolimogene oderparepvec,