Novartis' CAR-T Therapy Faces Quality, Safety Concerns At FDA Advisory Panel
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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Lengthy safety registries, extensive premarket testing for replication competent retrovirus, and manufacturing submission advice likely; pending CBER documents informed by review and approval of Novartis' Kymriah, Kite's Yescarta, and Spark's Luxturna.
Other CAR-T sponsors can only hope for the same kind of US FDA advisory committee success that Novartis enjoyed with tisagenlecleucel, an outcome that reflected the sponsor's experience and preparation, a lack of major show-stopping safety or product quality concerns, and robust efficacy in a narrow pediatric population.
US advisory committee's favorable views of Novartis' tisagenlecleucel-T suggest road map for other CAR-T developers to follow; with an Oct. 3 user fee deadline, pediatric leukemia agent is on path to becoming first chimeric antigen receptor T-cell therapy in US.