Replimune Faces CTGT Advisory Committee Review of Melanoma BLA on July 30, 2026

Regulatory affairs teams tracking advanced melanoma therapeutics have a firm calendar date: the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGT AdCom) will convene on July 30, 2026 to review Replimune's BLA 125827 for vusolimogene oderparepvec, an oncolytic immunotherapy proposed in combination with nivolumab for adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen.

The session runs 10:00 a.m. to 4:30 p.m. ET and will be conducted entirely via online video conference, accessible through a public YouTube livestream. Background materials are expected on the FDA Advisory Committee calendar no later than two business days prior to the meeting, giving regulatory teams a narrow window to review the agency's briefing documents before the committee deliberates.

The committee will issue non-binding recommendations; FDA is not legally obligated to follow them, though it generally does. For regulatory affairs leads monitoring the biologics pipeline, the committee's vote direction and the specific clinical and manufacturing questions raised during deliberations will signal how FDA is weighing the benefit-risk profile for this combination regimen in a previously treated population.

Public participation is structured around a formal docket. Comments submitted to docket FDA-2026-N-7231 on or before July 20, 2026 will be provided directly to the committee; comments received between July 21 and July 29 will be considered by FDA but not guaranteed to reach committee members before the session. The docket closes at 11:59 p.m. ET on July 29, 2026, and late submissions will not be considered. Electronic comments must be filed via regulations.gov; written submissions must be received by the same date.

An oral public comment period is scheduled between approximately 1:05 p.m. and 2:05 p.m. ET on the day of the meeting, providing a structured opportunity for stakeholders to present data or views directly before the committee.

The July 20 comment deadline represents the operative checkpoint for any organization intending to influence the committee record ahead of the BLA review.

Source: FDA What's New, Vaccines, Blood & Biologics RSS Feed via FDA.gov, July 8, 2026.