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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