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FDA lifts hold on Arcellx’s Gilead-partnered cancer cell therapy

August 15, 2023

CAR-T therapies are engineered from patients’ own T cells to attack cancer. The process requires the cells to be withdrawn from patients’ bodies and manufactured into the treatment, a time lag that makes recipients vulnerable to disease progression in the interim.

Chemotherapy, radiation and immunotherapy can keep cancer at bay. However, under the trial protocol the FDA approved for CART-ddBCMA, trial clinicians could only use treatments patients were previously exposed to and had progressed on. That may make bridging therapy less effective and put patients at risk of progression, according to a handbook on CAR-T treatment.

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