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Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) Meeting

Cellular, Tissue and Gene Therapies Advisory Committee · July 30, 2026

Advisory committee heard FDA reviewers and Replimmune present conflicting interpretations of IGNITE trial data for RP‑1 (visolimogene) plus nivolumab in PD‑1‑refractory advanced cutaneous melanoma; patients urged approval; committee voted that the evidence was evaluable and clinically meaningful (10–3).

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