The FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for adults with unresectable advanced cutaneous melanoma whose disease progressed with a PD-1-blocking antibody-based regimen.
Tudriqev is indicated in combination with nivolumab, according to an Aug. 6 FDA news release. Among 91 patients evaluated, 24% achieved an objective response, with a median response duration of 14.1 months.
The approval follows two previous FDA rejections. The agency issued complete response letters in July 2025 and April 2026 before allowing Replimune to resubmit its application in May.
On July 30, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy results from Replimune’s single-arm Ignyte study were evaluable and clinically meaningful.
The FDA granted the approval to Replimune. The company is required to conduct post-approval trials to verify and describe Tudriqev’s clinical benefit. Continued approval may be contingent on verification of clinical benefit in confirmatory trials.
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