USFDAAug 7, 2026, 06:11 AM
Replimune Gets FDA Accelerated Approval for TUDRIQEV in Melanoma
AI Summary
Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab. This approval is for the treatment of adults with unresectable advanced cutaneous melanoma who have experienced disease progression on an anti-PD-1 antibody-based regimen. The approval is based on objective response rate and duration of response from the IGNYTE trial, with continued approval contingent on confirmatory trials.
Key Highlights
- FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab.
- Indication is for adults with unresectable advanced cutaneous melanoma who progressed on anti-PD-1 therapy.
- Approval based on IGNYTE trial data showing an objective response rate (ORR) of 24.2% and median duration of response (DoR) of 14.1 months.
- Continued approval is contingent upon verification of clinical benefit in confirmatory trial(s), with IGNYTE-3 ongoing.
- TUDRIQEV is Replimune's first approved product, validating its RPx platform.
- The therapy was well-tolerated with mostly mild-to-moderate adverse events and no grade 4 or 5 common adverse events.
- The label allows for treatment of superficial, deep, and visceral lesions, including lung and liver.
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