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

Replimune Group, Inc.

FDA approved TUDRIQEV (vusolimogene oderparepvec-wtpg) + nivolumab on Aug 6, 2026 for unresectable advanced melanoma after anti-PD-1 progression.
IGNYTE trial: ORR 24.2%, median duration of response 14.1 months in 91-patient efficacy-evaluable population.
Confirmatory Phase 3 trial IGNYTE-3 (NCT06264180) ongoing; approval contingent on verification of clinical benefit.
Population included 80% Stage 4 disease, 54% PD-L1 negative, 45% lung and 24% liver lesions; treatment well tolerated.
Replimune now commercial stage; launching ReplimuneConnect Plus patient access, reimbursement and financial support program.

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