On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.
Tudriqev™ is a is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that is administered via direct intra-tumour injection into superficial and deep and/or visceral lesions.
The FDA approval comes despite the FDA’s 30 July 2026 briefing document for Replimune’s third submission of the Biologics License Application (BLA) for RP1 in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma.
The FDA’s briefing document stated in relation to Replimune’s IGNYTE study:
- The study’s “criteria for response assessment confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results”;
- “The objective response data from the single-arm IGNYTE study are not of sufficient magnitude to overcome concerns about the contribution of effect, particularly in the absence of a reliable historical control, and therefore it cannot be determined whether RP1 contributes to any observed effect when administered in combination with nivolumab”; and
- “The overall survival analysis from the single-arm IGNYTE study is not interpretable”.
According to Replimune, continued approval of Tudriqev™ may be contingent on verification of its clinical benefit in confirmatory trials. A confirmatory Phase 3 trial, IGNYTE-3, is ongoing and assessing Tudriqev™ in combination with nivolumab (NCT06264180).