- Key points from today's meeting of the FDA's Oncologic Drugs Advisory Committee as it discusses Novartis' (NYSE:NVS) Biologics License Application (BLA) seeking approval of CAR-T candidate CTL019 (tisagenlecleucel-T) for the treatment of pediatric and young adults with treatment-resistant B-cell acute lymphoblastic leukemia (ALL):
- Company representative Fisk says certain aspects of manufacturing process will not be addressed in public due to proprietary nature.
- Morris Plains facility has made more than 250 batches to date. Time to administration in commercial setting expected to be 22 days versus 16 weeks in clinical studies. Sees no problem meeting patient demand.
- Vestor-associated risks are low, but not eliminated. Novartis' Jason Hamilton says no correlation between number of cells infused and the emergence of cytokine release syndrome.
- Company plans to establish a patient registry for long-term follow-up. It does not plan to test patients for replication-competent lentivirus since the risk is low.
- Now read: Why Novartis Is A Cornerstone Of Our Portfolio
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