FDA Approves Replimune's Tudriqev for Advanced Melanoma After Two Rejections

The US Food and Drug Administration granted accelerated approval on August 6 to Replimune's Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed on a PD-1-blocking antibody-based regimen, according to the agency's approval notice.

The approval came on the therapy's third submission, after the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 in support on July 30, The Cancer Letter reported.

The evidence

The FDA evaluated Tudriqev in IGNYTE, an open-label, multiregional, single-arm trial of 140 adults with stage IIIB, IIIC or IV unresectable melanoma whose disease progressed after at least eight consecutive weeks of prior anti-PD-1 therapy. Among 91 patients in the efficacy-evaluable population, the objective response rate was 24.2% and the median duration of response was 14.1 months. Pharmacy Times describes IGNYTE as a Phase 2 trial.

Tudriqev is based on a modified herpes simplex virus type 1 that is engineered to infect and destroy cancer cells while prompting an immune response against the tumour, the FDA said in its announcement. It is injected directly into tumours every two weeks for eight doses, with nivolumab given intravenously from week three.

The most common adverse reactions included fatigue, fever, infections, chills, musculoskeletal pain, nausea, diarrhoea and injection site reactions. The label carries warnings for accidental spread of herpes infection to close contacts, herpes infection or reactivation in the patient, injection procedure complications and immune-mediated events.

"Today's important milestone gives oncologists a meaningful new tool — and more patients a fighting chance," said Karim Mikhail, acting director of the FDA's Center for Biologics Evaluation and Research.

The regulatory path

The FDA issued a complete response letter in July 2025 stating that IGNYTE was not an adequate and well-controlled study, citing heterogeneity in the enrolled population, and a second complete response letter followed in April 2026, Pharmacy Times reported. After the second letter, Replimune said it would scale back its US manufacturing operations and cut jobs, according to the outlet.

As a condition of accelerated approval, Replimune must run post-approval trials to verify the clinical benefit, and continued approval may depend on that verification. The randomised Phase 3 IGNYTE-3 trial compares Tudriqev plus nivolumab with physician's choice of therapy in patients whose melanoma progressed on both anti-PD-1 and anti-CTLA-4 regimens. The therapy had breakthrough therapy and priority review designations.