CBER’s director of clinical evaluation, Asha Das, overruled an FDA review team to grant accelerated approval to Replimune’s melanoma therapy Tudriqev (tudriqev), according to newly described agency documents. The decision followed a rejection earlier in the review cycle, underscoring how internal disagreement can shape high-stakes accelerated pathways. Replimune is now positioned for a faster U.S. rollout under accelerated approval, with confirmatory evidence expected later. The episode highlights the scrutiny still applied to confirmatory plans and the evidence bar for oncology biologics entering conditional regulatory territory.