FDA Panel Endorses Potential First US gene Therapy to Treat Leukemia

A panel of cancer experts Wednesday unanimously endorsed a leukemia treatment that could be the first gene therapy available in the U.S.

The Food and Drug Administration (FDA) advisory panel voted 10-0 to recommend approval of the treatment, which was devised by the University of Pennsylvania and Novartis Corp. The FDA is not required to follow the panel's recommendation, but often does.

The one-time treatment would be used on children and young adults with advanced leukemia.

The therapy could be the first of a wave of treatments custom-made to target a patient's cancer. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of cells that can recognize and destroy cancer and injecting them back into the patient.

"This is a major advance," said panel member Dr. Malcolm A. Smith of the National Cancer Institute. He said the treatment is "ushering in a new era."

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