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.
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Testing of autologous therapy in clinical trial patients who previously received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.
Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
The latest drug development news and highlights from our US FDA Performance Tracker.
Much like it did for the first biosimilars, US FDA approved Yescarta without an advisory committee, as Novartis' first-in-class CAR-T cell therapy already set the stage for an agency review.