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Replimune's Tudriqev now on US market for advanced melanoma after accelerated approval

🇺🇸 Replimune Group, Inc. (REPL) · Wed 28 Oct 2026

Replimune says its oncolytic HSV-1 therapy, given with nivolumab, became commercially available in early October, with NCCN listing and payer policies emerging while the confirmatory Phase 3 trial enrols.

Replimune Group reported in its quarterly update of 28 October 2026 that Tudriqev (vusolimogene oderparepvec-wtpg) became commercially available in the United States in early October. The product is an oncolytic herpes simplex virus type 1 (HSV-1) therapy.

Tudriqev is used in combination with nivolumab in adults with unresectable advanced cutaneous melanoma whose disease progressed after treatment with a PD-1 inhibitor.

The company said the therapy has been added to the National Comprehensive Cancer Network (NCCN) guidelines as a category 2A recommendation. It also said several payers have already published coverage policies for the product.

The indication was granted under accelerated approval, on the basis of response rate and duration of response. Replimune said the confirmatory Phase 3 trial, IGNYTE-3, is enrolling, and continued approval may depend on its results. As general context, accelerated approval in the US allows products for serious conditions to reach patients on surrogate or intermediate endpoints, with confirmatory evidence required afterwards.

What it means for your team

  • Market-access teams should track the growing set of payer coverage policies, as the company reports several are already published.
  • Regulatory teams should note that the accelerated approval is tied to response-rate and duration-of-response data, with continued approval potentially dependent on IGNYTE-3.
  • Pharmacovigilance and medical teams may want to follow early real-world use in patients who progressed after PD-1 therapy, now that the product is commercially available.

Company's press release (SEC filing): Replimune Group, Inc. ↗

Article written by VigiEye from the official source (Replimune Group, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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