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Innovative Cancer Treatment May Sometimes Cause Cancer, F.D.A. Says

A lifesaving cancer treatment may itself cause cancers, the Food and Drug Administration reported on Tuesday.

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 F.D.A. has approved six commercial CAR-T products. Cancer specialists said the treatments have saved the lives of thousands of patients with blood cancers. 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. That sentiment was echoed by doctors involved in cancer treatment.

While the hypothetical risk was known, “we haven’t observed it” in patients, Dr. Marcela V. Maus, director of cellular immunotherapy at Massachusetts General Hospital, said.

Dr. John DiPersio, director of the center for genetic and cellular immunotherapy at Washington University School of Medicine in St. Louis, said his center had treated 500 to 700 patients. And, he said, “I haven’t seen a single one” develop a new T cell cancer.

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