Replimune Group is awaiting a delayed FDA decision on RP1 after advisers voted that its melanoma results were clinically meaningful. Approval would create a more accessible oncolytic immunotherapy option, but regulators remain divided over whether the single-arm IGNYTE trial reliably proves RP1’s contribution.
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,
The FDA has accepted Replimune’s latest RP1 resubmission and set an August 2 decision date, reviving a melanoma programme rejected twice over trial-design and efficacy questions. A late-July advisory committee will determine whether durable responses can outweigh the absence of definitive controlled evidence.