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.