FDA push­es back de­ci­sion on J&J, Leg­end's BC­MA CAR-T

Bris­tol My­ers Squibb and blue­bird can hold on to their sta­tus as the mak­ers of the on­ly ap­proved BC­MA CAR-T for a bit longer.

The FDA — which was sched­uled to make a de­ci­sion on Leg­end and J&J’s cil­ta-cel on Nov. 29 — has de­layed that by three months and ex­tend­ed the PDU­FA date to Feb. 28.

Ac­cord­ing to the part­ners, the agency no­ti­fied J&J’s Janssen of the ex­ten­sion on Oct. 28, cit­ing the need for time to re­view re­cent­ly sub­mit­ted in­for­ma­tion “per­tain­ing to an up­dat­ed an­a­lyt­i­cal method fol­low­ing an FDA in­for­ma­tion re­quest.” Leg­end and Janssen then met with reg­u­la­tors on Mon­day. No ad­di­tion­al clin­i­cal da­ta are be­ing re­quest­ed, they added.

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