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

 
• By Sue Sutter

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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The first US FDA Oncologic Drugs Advisory Committee review of a chimeric antigen receptor T-cell therapy – Novartis AG's pediatric leukemia treatment tisagenlecleucel-T (CTL-019) – probably could not have gone better for a first-in-class product that carries some serious risks.

The July 12 meeting's successful outcome for Novartis was likely the result of a host of case-specific factors: a well-prepared, experienced sponsor that appeared to be on good relations with FDA and came in with a risk mitigation strategy informed by clinical experience; a lack of major show-stopping safety or product quality

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EU CHMP Opinions And MAA Updates

 
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