Replimune Group announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec). The application seeks accelerated approval for RP1 in combination with nivolumab for the treatment of advanced melanoma.

Key Details

  • Product & Indication: RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma who have progressed on an anti-PD-1 regimen.
  • Regulatory Milestone: The FDA has classified the resubmission as a complete, class 1 response and accepted it for review.
  • Timeline: The FDA has set a goal date of August 2, 2026, for its decision. An advisory committee meeting is anticipated in late July 2026.