Novartis CAR-T Site Selection, Risk Management Are Model For Other Sponsors

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.

A US FDA advisory committee's unanimous endorsement of Novartis AG's tisagenlecleucel-T (CTL019) for pediatric leukemia July 12 not only moves the chimeric antigen receptor T-cell therapy closer to commercialization, it provides a benchmark for other CAR-T product developers to follow when it comes to risk mitigation strategies.

All 10 voting members of the Oncologic Drugs Advisory Committee said tisagenlecleucel had a favorable risk/benefit profile for pediatric and young adult patients with

Advisory Committee Vote

Is the benefit/risk profile of tisagenlecleucel favorable for treatment of pediatric and young adult patients (age 3-25 years) with relapsed (second or later relapse) or refractory (failed to achieve remission to initial induction or

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