FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
Regulatory approval: The FDA granted accelerated approval (Aug 6, 2026) to vusolimogene oderparepvec-wtpg (Tudriqev) plus nivolumab for adult unresectable advanced cutaneous melanoma that progressed on a PD-1–blocking antibody regimen. Approval was based on objective response rate and duration of response from the single-arm IGNYTE trial. Confirmatory post-approval studies are required, and continued approval may depend on verification of clinical benefit.
FDA accelerated approval (regulatory approval)
On Aug 6, 2026, the FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev; Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma with disease progression on a PD-1–blocking antibody-based regimen.
The application was discussed at an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting on Jul 30, 2026, which included a public hearing and committee deliberations.
Evidence supporting approval
Approval under the accelerated approval pathway was based on objective response rate (ORR) and duration of response (DOR) from IGNYTE (NCT03767348), an open-label, multiregional, single-arm trial. The study enrolled 140 adults with Stage IIIB/IIIC/IV unresectable advanced melanoma with progression after ≥8 consecutive weeks of prior anti–PD-1–based therapy; 91 patients with at least one noninjected lesion comprised the efficacy-evaluable population. ORR was 24.2% (95% CI 15.8–34.3) and median DOR was 14.1 months (95% CI 10.7–not reached).
Post-approval requirement and safety
As a condition of accelerated approval, post-approval trial(s) are required to verify and describe clinical benefit; continued approval may be contingent on confirmatory results.
Label warnings/precautions include accidental exposure, herpetic infection/reactivation, injection procedure complications, and immune-mediated events. Common non-laboratory adverse reactions (>10%) included fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza-like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.