FDA grants accelerated approval to Replimune's TUDRIQEV plus nivolumab for melanoma

Replimune Group announced on August 6, 2026 that the FDA granted accelerated approval to TUDRIQEV (vusolimogene oderparepvec-wtpg), formerly called RP1, for use with nivolumab. The approval covers adults with unresectable advanced cutaneous melanoma who progressed after treatment with an anti-PD-1 antibody-based regimen, and it was granted based on objective response rate and duration of response.¹ Continued approval for this indication may depend on confirming clinical benefit in one or more follow-up trials.¹

The approval rests on data from the IGNYTE trial. Of 140 patients enrolled, 91 with at least one non-injected lesion made up the efficacy-evaluable population, where the combination produced a 24.2% objective response rate and a median duration of response of 14.1 months.¹ Patients in the study included those with Stage 4 disease (80%), prior adjuvant anti-PD-1 treatment (13%), PD-L1 negative status (54%), and lung (45%) or liver (24%) lesions.¹

On safety, serious adverse reactions occurred in 35% of the 140 treated patients, and 2.9% discontinued treatment permanently due to adverse reactions including single cases each of amylase increase, lipase increase, myocarditis, and pneumonitis.¹

TUDRIQEV is a modified type 1 herpes simplex virus built on Replimune's RPx platform. It carries a fusion protein taken from gibbon ape leukemia virus, engineered so that it lacks a particular sequence (called GALV-GP-R–), along with the gene for human GM-CSF, and the genes for the HSV-1 factors ICP34.5 and ICP47 have been removed from the virus.¹

To confirm clinical benefit, Replimune is running a Phase 3 trial called IGNYTE-3, testing TUDRIQEV with nivolumab under registration number NCT06264180.¹ The company held a webcast the same day to discuss the approval.