Atara Biotherapeutics and Pierre Fabre said FDA agreed to reconsider approval of Ebvallo after a surprise rejection earlier this year, following a late-April meeting. The companies said FDA’s main reason for rejection—assertions that their already completed single-arm phase 3 study was insufficient—was walked back. Atara framed the outcome as FDA agreeing the completed trial can support a review and potential approval. The dispute is closely tied to leadership changes at FDA’s Center for Biologics Evaluation and Research, where Vinay Prasad had led at the time of the January rejection and departed at the end of April. The companies’ next steps are expected to follow the renewed FDA pathway for reassessing the evidence. For the sector, the episode underscores how regulators can pivot on evidentiary standards in rare oncology, with direct consequences for clinical-trial design expectations and potential approval timelines.