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8h ago

Replimune Reports No Defined Accelerated-Approval Path After FDA Type A Meeting on RP1 for Melanoma

Regulatory uncertainty persists pending further FDA direction on evidentiary requirements.

Path Toward Accelerated Approval of RP1 in Advanced Melanoma Remains Unclear After FDA Type A Meeting

Overview

  • Replimune said it completed a Type A meeting with the FDA on September 16 to discuss the complete response letter for its RP1 plus nivolumab biologics license application in advanced melanoma.
  • The company stated that a path toward accelerated approval has not been determined and that it is evaluating the agency's feedback to decide next steps.
  • The FDA’s July complete response letter concluded the phase 1/2 IGNYTE study was not an adequate and well-controlled investigation to provide substantial evidence for approval.
  • A randomized phase 3 confirmatory trial, IGNYTE-3 (NCT06264180), remains ongoing to compare RP1 plus nivolumab with physician’s choice in advanced melanoma after anti–PD-1 and anti–CTLA-4 therapy.
  • IGNYTE’s registration-intended cohort reported a confirmed overall response rate of 33.6% with a 15.0% complete response rate, and safety was largely grade 1–2 with 12.8% grade 3–4 treatment-related events and no grade 5 events.