Senior officials at the FDA’s Center for Biologics Evaluation and Research signalled a policy shift that will generally require randomized controlled trials (RCTs) with survival or time‑to‑event endpoints to support approvals of CAR‑T cell therapies, except in narrowly defined circumstances. The agency outlined its experience with prior single‑arm approvals and stated RCTs will be preferred going forward. The change raises the evidentiary bar for developers of cell therapies, influencing clinical strategy, trial design and timelines. Sponsors developing CAR‑T candidates will likely need larger, controlled registrational programs, altering investment and development economics for next‑generation and niche CAR‑T approaches. Source: reporting summarizing FDA leadership statements and an article in JAMA from CBER officials.