The FDA signaled a policy shift that will require new CAR‑T therapies to demonstrate superiority over existing treatments to secure approval, according to a journal article by the agency’s biologics chief. Regulators will expect trials designed to show clear benefit on clinical endpoints versus available standards rather than relying solely on single‑arm comparisons or surrogate markers. The change will affect trial design, timelines and commercial prospects for emerging CAR‑T developers and may prompt sponsors to pursue larger, more demanding randomized programs.