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Novartis' CAR-T Therapy Faces Quality, Safety Concerns At FDA Advisory Panel

Executive Summary

Unusual meeting agenda indicates that effectiveness of tisagenlecleucel-T in acute lymphoblastic leukemia is not a primary issue for US FDA advisory committee consideration at first-ever review of a CAR-T therapy; agency's draft questions focus on product quality considerations and measures for mitigating risk of cytokine release syndrome.

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