FDA panel favors new leukemia therapy
A panel of cancer experts Wednesday recommended approval of what could become the first gene therapy available in the U.S.
The Food and Drug Administration advisory panel voted 10-0 in favor of an advanced leukemia treatment developed by the University of Pennsylvania and Novartis Corp. The FDA usually follows recommendations of its expert panels but isn’t obligated to do so.
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 patient’s blood, reprogramming them to create an army of cells that can zero in on and destroy cancer cells, and injecting them back into the patient.
“This is a major advance,” said panel member Dr. Malcolm Smith of the National Cancer Institute. He said the treatment is “ushering in a new era.”