The FDA’s biologics chief signaled a policy shift requiring new CAR‑T cancer therapies to demonstrate superiority over existing treatments to secure approval. The position, articulated in a recent journal article, raises the evidentiary bar for developers pursuing CAR‑T approvals and could reshape trial design expectations, pushing sponsors toward randomized or active‑comparator studies. Companies and investors should anticipate longer, potentially more costly registrational programs as regulators push for comparative benefit rather than non‑inferiority or single‑arm efficacy readouts.