for advanced melanoma after prior anti-PD-1 therapy
BLA· Priority Review · Breakthrough
Originally APR 10 2026; extended to AUG 2 2026
(FDA issued CRL on the second resubmission cycle in April 2026. Following collaborative FDA discussions, Replimune resubmitted May 29, 2026; FDA accepted the resubmission June 26, 2026 as Class 1 (minor amendment) with 2-month review clock producing Aug 2 PDUFA. FDA notified sponsor to expect a CTGTAC advisory committee meeting in late July before the decision., announced JUN 26 2026).
About
RP1 is a modified cold sore virus designed to infect and destroy cancer cells directly while also stimulating the body's immune system against the tumor. It is being studied for advanced melanoma that has continued to progress despite standard immunotherapies. This approach may offer a new way to attack the cancer from within and reactivate an immune response.
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.
→APR 10 2026 shifted to AUG 2 2026 (FDA issued CRL on the second resubmission cycle in April 2026. Following collaborative FDA discussions, Replimune resubmitted May 29, 2026; FDA accepted the resubmission June 26, 2026 as Class 1 (minor amendment) with 2-month review clock producing Aug 2 PDUFA. FDA notified sponsor to expect a CTGTAC advisory committee meeting in late July before the decision.; announced JUN 26 2026)
