FDA Votes Yes on CAR T-Cell Therapy

A Food and Drug Administration advisory panel unanimously calls for agency approval of the cell therapy for the treatment of resistant leukemia.

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A US Food and Drug Administration (FDA) advisory committee unanimously voted yesterday (July 12) to recommend the approval of a chimeric antigen receptor T-cell (CAR T) therapy for difficult-to-treat acute lymphoblastic leukemia, The New York Times reports. The FDA is expected to go by the committee’s recommendation and move forward with approving the treatment for children and young adults by October 3, according to STAT.

The cell therapy has produced stunning remissions in patients with stubborn cancers and will usher in “a new era in medicine,” reports The New York Times, as it will be the first of its kind to become commercialized.

CAR T-cell therapy takes a patient’s T cells and genetically arms them with receptors that target cancer cells. In the case of this leukemia therapy—Novartis’s CTL019—the T cells are engineered to target a surface antigen specific to ...

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