FDA lifts partial hold on Arcellx’s Gilead-partnered blood cancer cell therapy as biotech aims for 2026 launch

Ar­cel­lx’s Gilead-part­nered mul­ti­ple myelo­ma cell ther­a­py is in the clear, as the FDA has re­moved the par­tial clin­i­cal hold it placed on the CAR-T can­di­date in June fol­low­ing a pa­tient death.

The Cal­i­for­nia drug­mak­er said Mon­day that the pa­tient who died was “man­aged in a man­ner that con­flict­ed with the tri­al pro­to­col.” The pa­tient was treat­ed with the ther­a­py even though they were in­el­i­gi­ble for it un­der the pro­to­col, Ar­cel­lx added.

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