The treatment, called CAR-T was first approved in November 2017 for life-threatening blood cancers. But, the F.D.A. said, it had received 19 reports of new blood cancers in patients who received the treatment.
CAR-T involves removing a type of white blood cell (T cells) from a patient's blood, then genetically engineering to make proteins (chimeric antigen receptors - CAR) which allow the T cells to attach to cancer cells and kill them. The engineered cells are then infused back into the patient's blood. The FDA has approved six commercial CAR-T products.
Even if there is a causal link between the treatments and a small risk of a new blood cancer, the regulators said on Tuesday, the benefits of the treatment outweigh the risks.
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