Replimune, Inc. : lettre de réponse complète (BL 125827)

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i Lk Fy" U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125827 COMPLETE RESPONSE APRIL 10, 2026 Replimune, Inc. Attention: Kari Jeschke 500 Unicorn Park Drive Woburn, MA 01801 Dear Kari Jeschke: Please refer to your Biologics License Application (BLA) received (1b) (4) ; ‘or vusolimogene oderparepvec, submitted under section 351(a) of the Public Health Service Act. We acknowledge receipt of your amendment dated October 9, 2025, which constituted a complete response to our July 21, 2025, action letter. We have completed a comprehensive review of all the submissions relating to this BLA ‘or vusolimogene oderparepvec in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based therapy. We performed a reanalysis of data from study RPL-001-16 along with the review of additional data from study RP1-104. To maintain objectivity and account for potential bias, the review team members for this BLA resubmission were different than those who reviewed the initial BLA. This BLA resubmission primary clinical review team, supervisory leadership in the Office of Therapeutic Products, and subject matter experts tom Oncology Center of Excellence unanimously determined data presented are insufficient to conclude substantial evidence of effectiveness of vusolimogene oderparepvec for treatment of unresectable advanced cutaneous melanoma. FDA advice has remain

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