The FDA’s biologics chief argued in a journal article that new CAR‑T therapies will need to demonstrate superiority over existing standards to secure approval, signaling a tougher regulatory path for entrants. The higher evidentiary bar comes as fresh pivotal‑stage CAR‑T data show deep responses for next‑generation constructs, creating a direct test of the agency’s stance. At ASH, Gilead and Arcellx presented pivotal multiple myeloma CAR‑T data with 96% overall response and 74% complete remission rates in the enrolled cohort, alongside manageable safety observations, per company releases. Those high efficacy figures strengthen the case that some new CAR‑T programs may meet an elevated superiority standard, particularly if durability and safety compare favorably to incumbents. CAR‑T (chimeric antigen receptor T‑cell) therapies are engineered patient T cells that target tumor antigens; regulatory expectations for head‑to‑head or external‑control superiority would raise trial complexity and costs across the field.