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.
The United States Food and Drug Administration (FDA) has granted accelerated approval to Replimune Group’s Tudriqev in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed during a programmed death receptor-1 blocking treatment. The August 6, 2026 decision gives oncologists a new option for a difficult stage of melanoma treatment, when tumours
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.