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Novartis CAR-T AdComm Was Smooth Sailing, But Will That Be An Anomaly?

Executive Summary

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.

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