FDA Orders Drugmakers to Add Cancer Warning to CAR-T Treatments

FDA Orders Drugmakers , to Add Cancer Warning to , CAR-T Treatments.

This week, the Food and Drug Administration ordered drugmakers to add a warning to CAR-T cancer therapy, saying that the treatment may increase the risk of cancer.

NBC reports that a spokesperson for the FDA said that despite the warning being ordered, , "the overall benefits of these products continue to outweigh their potential risks.".

According to spokesperson Carly Kemper, the FDA's decision was prompted by reports of CAR-T patients developing rare forms of blood cancer.

Kemper said that as of January 22, the agency had recorded 25 cases of CAR-T patients developing blood cancer.

NBC reports that CAR-T, short for chimeric antigen receptor T cell, uses a patient's own immune cells to treat certain types of blood cancers.

T cells are harvested, genetically altered to make them target cancer cells and then reinfused into the patient.

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According to experts, the treatment has been highly effective in hard-to-treat cases.

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This has been a game changer when we think about treating lymphoma and other diseases, Dr. Matthew Frigault, clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program in Boston, via NBC.

NBC reports that the first CAR-T therapy received FDA approval in 2017 with Novartis' drug, Kymriah.

Another five drugs have since received FDA approval