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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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.
Multi-luminance mobility testing was developed by firm to measure functional vision across a range of lighting levels in patients with RPE65 mutations; advisory committee also will consider minimum patient age and clinical stage of disease appropriate for subretinal injections with voretigene.