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FDA issues warning of secondary cancer risk linked to CAR-T therapies

The FDA sent notification letters to several manufacturers of the therapies, requiring them to add a “boxed warning” to the products’ prescribing information.

The US Food and Drug Administration has issued a warning about the possible risk of secondary cancers in patients who have been treated with a certain type of cancer therapy.

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The FDA sent notification letters to several manufacturers of chimeric antigen receptor T-cell, or CAR-T cell cancer therapies, requiring them to add a “boxed warning” to the products’ prescribing information.

CAR-T therapy is a form of immunotherapy, or therapy that uses substances made by the body or in a laboratory to boost the immune system and help the body find and destroy cancer cells, according to cancer.net.

CAR-T therapy takes the body’s T-cells, a type of white blood cell, alters them, and then they are put back into the patient through an infusion.

As of this week, the agency has received 25 reports of T-cell malignancy after treatment with CAR-T cell immunotherapies, according to the email.

“We would like to underscore that the overall benefits of these products continue to outweigh their possible risks,” FDA spokesperson Carly Pflaum said in an email Wednesday.

As of the end of last year, the FDA had received 22 reported cases of different types of T-cell malignancies possibly associated with CAR-T therapies, CNN reported. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, announced the number in a presentation at the Alliance for Regenerative Medicine.

Marks noted that that number was out of 27,000 people who are being treated with CAR-T therapies in the United States.

Patients and people participating in clinical trials who are receiving these therapies should be monitored “life-long” for any new malignancies, according to the agency.

The F.D.A. issued letters to these companies: Bristol-Myers Squibb, maker of Abecma; Juno Therapeutics, a Bristol-Myers Squibb Company, maker of Breyanzi; Janssen Biotech of Johnson & Johnson, maker of Carvykti; Novartis, of Kymriah; and Kite Pharma, of Yescarta.

“The FDA considers the serious risk of T cell malignancy to apply to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies,” the FDA said in a news release Tuesday.

While the warnings are concerning, the risk of secondary cancer doesn’t appear to be high.

“On an individual basis, a patient should not be too worried about this specific risk of developing treatment-induced T cell lymphoma after receiving CAR-T cell therapies, the risk appears to be extremely low,” Dr. Joshua Brody, director of the lymphoma immunotherapy program at the Tisch Cancer Institute at Mount Sinai, told CNN.

The FDA noted that the benefits still outweighed the risks of the therapy.

Cancer patients who receive CAR-T treatments tend to have few options left, Dr. John DiPersio, an oncologist with Washington University in St. Louis told The New York Times.

The potential risks with CAR-T would be unlikely to alter the treatment course, he said.

“The risk of not doing this therapy for most patients who get it is rapid progression of their disease or certain death,” he said.

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