FDA’s biologics office rejected and then reversed course on its review of Replimune’s melanoma therapy Tudriqev (Tudriqev), according to newly disclosed documents. The CBER official Asha Das, director of the FDA’s Office of Clinical Evaluation, overruled the review team’s rejection and granted an accelerated approval decision earlier in August. The episode highlights how accelerated pathways for oncology products can still hinge on internal agency power dynamics and evidence interpretation, even when a program reaches the threshold for consideration. Replimune’s submission and the FDA’s decision-making process will likely draw attention from stakeholders watching how confirmatory evidence expectations are handled. For industry, the case is another reminder that accelerated approvals may involve additional scrutiny not only from external panels, but also from within the agency’s own review chain.