FDA panel endorses potential 1st US gene therapy for leukemia treatment

Close-up medical syringe with needle is lying on a table (Think Stock Photo)

SILVER SPRING, Md. (AP) – The Latest on a Food and Drug Administration panel’s review of a gene therapy treatment (all times local):

3:30 p.m.

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.

10:30 a.m.

Cancer experts who advise government regulators are reviewing what could be the first gene therapy approved in the U.S. The Food and Drug Administration panel is holding a hearing Wednesday to discuss the treatment developed by the University of Pennsylvania and Novartis Corp. The drugmaker is seeking approval to use the one-time treatment for children and young adults with advanced leukemia.

The therapy could be the first of a wave of cancer 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 attack cells and putting them back into the patient.

The panel is reviewing the safety, effectiveness and production of the treatment. It will vote on whether to recommend FDA approval.

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