Replimune says FDA grants accelerated approval for TUDRIQEV plus nivolumab in advanced melanoma after anti-PD-1 progression
REPL•FDA grants accelerated approval
FDA granted accelerated approval for Replimune’s TUDRIQEV with nivolumab in unresectable advanced cutaneous melanoma progressing on anti-PD-1 therapy.
Basis for approval and next steps
Approval was based on IGNYTE objective response rate of 24.2% with median duration of response of 14.1 months.
Continued approval hinges on confirmatory evidence; Phase 3 IGNYTE-3 trial is ongoing.
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