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FDA Approval Recommendation for CAR T-Cell Therapy

July 14, 2017

The CAR T-cell therapy developed at Penn by Dr. Carl June and colleagues was recommended unanimously by an expert FDA advisory committee as the first-ever genetically targeted, cell-based therapy for the treatment of cancer for the treatment of children and young adults with advanced leukemia. The vote was the last step prior to the formal approval for sale by Novartis, Penn’s collaborator to research and develop CTL019 and other chimeric antigen receptor (CAR) T cell therapies. The FDA is expected to make a final decision on approval by October 3. Groundbreaking work on this form of personalized therapeutics in cancer immunotherapy was provided by Department faculty members Drs. Carl June, Bruce Levine, Don Siegel, Mike Milone, and Adam Bagg, among others.
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