Federal Register #FDA2026N7231

FDA Announces Public Advisory Committee Meeting on Cellular, Tissue, and Gene Therapies

The Food and Drug Administration (FDA) is convening a public advisory committee meeting focused on regulatory issues in cellular, tissue, and gene therapies. - The meeting will specifically review Biologics License Application (BLA) 125827 from Replimune, Inc. - Product under review: vusolimogene oderparepvec - Intended use: In combination with nivolumab for adults with advanced melanoma who have previously received an anti-PD1 regimen - The event is open to the public and includes a docket for public comments - No procurement, contracting, or awards are associated with this event - Replimune, Inc. is the only OEM/vendor mentioned, related to the product under review - The meeting is for regulatory and public engagement purposes only

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee scheduled for July 30, 2026. The committee will provide advice and recommendations to FDA on regulatory issues related to cellular, tissue, and gene therapies. The meeting will discuss Biologics License Application (BLA) 125827 from Replimune, Inc. for vusolimogene oderparepvec, intended for use in combination with nivolumab for treating adult patients with advanced melanoma who have previously received an anti-PD1 regimen. The meeting will be held virtually and is open to the public, with a docket established for public comments.

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