FDA Approves Twice-Rejected Oncolytic Virus Combination for Melanoma

The US Food and Drug Administration granted accelerated approval on August 6 to vusolimogene oderparepvec-wtpg (Tudriqev) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD-1-blocking antibody-based regimen, Oncology News Central reported. The decision comes after the agency twice rejected the combination — most recently this April over efficacy trial design concerns — and follows a 10-3 advisory committee vote in July affirming that the results were clinically meaningful.

The Trial Behind the Approval

The open-label, single-arm Phase 1/2 IGNYTE trial enrolled 140 adults with stage IIIB, IIIC, or IV unresectable melanoma, all of whom had progressed after at least eight consecutive weeks of prior anti-PD-1 therapy. The objective response rate was 24.2%, and the median duration of response was 14.1 months. When the 49% of patients whose lesions were all injected with the virus were excluded — as FDA reviewers argued RECIST criteria required — the response rate fell to 15.7%.

How It Works

Tudriqev is an oncolytic virus — a modified herpes virus designed to infect and destroy tumor cells while provoking an immune response — paired with nivolumab, the PD-1 checkpoint inhibitor. For patients who have exhausted PD-1 therapy, the regimen offers a new mechanism entirely: a virus engineered to attack the tumor directly.

Post-Market Conditions

The FDA noted that Replimmune Inc., the drug's sponsor, is required to conduct at least one post-approval trial, and that conversion to traditional approval is contingent on those results verifying clinical benefit. Melanoma remains one of the fastest-moving areas of oncology, with oncolytic viruses long considered promising but historically difficult to bring through the approval process.