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FDA Grants Accelerated Approval for Tudriqev-Opdivo Melanoma Therapy

8/7/2026

Summary

Story summary

FDA granted accelerated approval to Replimune’s Tudriqev with Opdivo for adults with unresectable advanced melanoma after anti-PD-1 failure.
The IGNYTE single-arm trial of 140 patients showed a 24.2% objective response rate and a median response duration of 14.1 months, leading a 10-3 advisory committee vote on July 30.
The therapy costs $450,000 per course, analysts forecast U.S. sales near $1 billion, and approval depends on a confirmatory trial readout due in 2030.

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Story summary

FDA granted accelerated approval to Replimune’s Tudriqev with Opdivo for adults with unresectable advanced melanoma after anti-PD-1 failure.
The IGNYTE single-arm trial of 140 patients showed a 24.2% objective response rate and a median response duration of 14.1 months, leading a 10-3 advisory committee vote on July 30.
The therapy costs $450,000 per course, analysts forecast U.S. sales near $1 billion, and approval depends on a confirmatory trial readout due in 2030.