for advanced melanoma after prior anti-PD-1 therapy
BLA· Priority Review · Breakthrough
Third review cycle. Prior two cycles both resulted in CRLs (July 2025 and April 2026, both citing trial-design and comparator concerns). FDA accepted the current resubmission June 26 2026 as Class 1 with an Aug 2 PDUFA and convened the CTGTAC AdComm on July 30, 2026. Committee voted 10-3 that the IGNYTE study efficacy results are evaluable and clinically meaningful — a favorable outcome that removes the panel-level hurdle FDA had cited across the two prior CRL cycles. PDUFA decision expected August 2, 2026.
About
Advanced melanoma is a serious form of skin cancer that can spread to other parts of the body and become difficult to treat. Tudriqev is a modified cold sore virus designed to infect and destroy cancer cells directly while also activating the body's immune system against the tumor. This dual action could provide a new treatment option for patients whose melanoma has continued to progress despite standard immunotherapies.
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)
