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FDA approves personalized cellular therapy for advanced leukemia

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In a landmark decision for the field of cancer immunotherapy, the U.S. Food and Drug Administration (FDA) today approved a personalized cellular therapy developed by the University of Pennsylvania and Children's Hospital of Philadelphia (CHOP) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. The approval was granted to Novartis for the chimeric antigen receptor (CAR) T-cell therapy, Kymriah™ (tisagenlecleucel, formerly CTL019). In 2012, Penn and Novartis entered into a global collaboration to further research, develop and commercialize Kymriah and other CAR-T cell therapies for the treatment of cancers. Kymriah is the first therapy based on gene transfer approved by the FDA.

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