On July 30, the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) issued a favorable 10–3 determination that Replimune’s IGNYTE data for vusolimogene oderparepvec (RP1) in unresectable advanced cutaneous melanoma were “evaluable and clinically meaningful.” The committee’s support follows two earlier FDA declines for the accelerated-approval approach in combination with nivolumab (Opdivo). The advisory vote centers on how investigators handled response-evaluable lesions under RECIST 1.1. FDA reviewers had flagged execution concerns, including that 49% of patients had all target lesions injected, which—under RECIST rules—would exclude those lesions from evaluation. When those cases were removed, the reported objective response rate dropped to 15.7% from 33.6% in the initial analysis. While advisory committee recommendations do not bind FDA, the result is likely to influence the agency’s next regulatory step for accelerated approval in a setting where options after PD-1 inhibitor progression remain limited.