FDA panel endorses potential 1st US gene therapy

MGN

SILVER SPRING, Md. (AP) - A panel of cancer experts has voted in favor of a leukemia treatment which could be the first gene therapy available in the U.S.

The Food and Drug Administration advisory panel voted 10-0 on Wednesday to recommend approval of the treatment developed by the University of Pennsylvania and Novartis Corp. The one-time treatment would be for 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 to recognize and destroy cancer and injecting them back into the patient.

The FDA is not required to follow the panel's recommendation but often does.



 
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