The US Food and Drug Administration has granted accelerated approval to TUDRIQEVTM (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following treatment with a PD-1–blocking antibody-based regimen.
The decision gives a new treatment option to patients with advanced melanoma whose disease has stopped responding to one of the most widely used forms of immunotherapy.
Tudriqev, developed by Replimune, is a genetically modified oncolytic viral therapy based on herpes simplex virus type 1 (HSV-1). It is injected directly into tumors, where the modified virus is designed to selectively infect and destroy cancer cells while stimulating an immune response against the tumor.
What did the trial show?
The accelerated approval was supported by the open-label, multiregional, single-arm IGNYTE trial, which enrolled 140 adults with Stage IIIB, IIIC, or IV unresectable advanced melanoma who experienced disease progression following prior anti-PD-1 therapy.
Among 91 patients included in the efficacy analysis, 24% achieved an objective response, with responses lasting a median of 14.1 months.
Tudriqev is administered directly into tumors once every two weeks for eight consecutive doses, while nivolumab is administered intravenously beginning during the third week of treatment.
An approval after significant regulatory debate
The approval follows an unusual regulatory path for Tudriqev, previously known as RP1.
The FDA initially declined to approve the therapy in July 2025, concluding that the IGNYTE trial did not provide adequate and well-controlled evidence of effectiveness and raising concerns about the heterogeneity of the study population.
After Replimune resubmitted its application, the FDA issued another Complete Response Letter in April 2026. The agency again questioned whether the single-arm study could establish the effectiveness of the combination, including whether the contribution of Tudriqev could be separated from that of nivolumab.
Regulatory concerns remained shortly before the eventual approval. In briefing documents released ahead of a July 30 advisory committee meeting, FDA reviewers said the application still lacked an adequate and well-controlled study demonstrating substantial evidence of effectiveness and raised questions about how treatment responses were assessed.
However, at the July 30, 2026 Cellular, Tissue, and Gene Therapies Advisory Committee meeting, external advisers ultimately voted 10–3 that the available data could be evaluated and demonstrated a clinically meaningful benefit for patients with advanced melanoma.
For the full picture of Tudriqev’s regulatory journey leading up to this approval, read OncoDaily’s previous coverage:
Third Time at the Table: Why Replimune’s RP1 Deserves a Real Hearing in Post-PD-1 Melanoma
The approval was granted through the FDA’s accelerated approval pathway, based on objective response rate and duration of response. Replimune will be required to conduct post-approval studies to confirm the clinical benefit of Tudriqev plus nivolumab, and continued approval may depend on the results of confirmatory trials.
Read the full News Release.