FDA to consider new gene therapy for cancer treatment

The U.S. Food and Drug Administration advisory committee unanimously recommended the agency approve a unique "living drug" approach to treat a common form of leukemia in children and young adults, according to NPR

The treatment is referred to as CART-T cell immunotherapy. It works by removing a patient's T cells — vital type of immune system cells — for scientists to genetically engineer and later reinsert into the body to target a patient's cancer cells. The therapy employ's a patient's own immune system to fight the disease, which is why some scientists call it a "living drug."

The drug, developed by Novartis, is called CTL019. The company is seeking FDA approval for the drug, which would treat patients ages 3 to 25 who have relapsed after undergoing standard treatment fom B cell acute lymphoblastic leukemia — the most common childhood cancer in the U.S.

In the main study Novartis submitted as evidence to the FDA, physicians used the drug to treat 88 patients. The drug produced remissions in 83 percent of patients, Novartis told the committee, according to NPR.

However, a few patients who received a similar treatment developed by other companies died from serious brain swelling, NPR notes. The long-term complications of these treatments are still unknown, although CTL019 patients recovered and there were no fatalities.

If approved, this would mark the first time the FDA approved any drug considered a "gene therapy product."

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