July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
If you have any interest in the CAR-T field, mark down Wednesday, July 12 as a red letter day.
The FDA posted a note on Tuesday saying that its group of outside cancer experts will gather that day to discuss the pharma giant’s application and vote on whether Novartis $NVS should get a marketing approval for its leading CAR-T CTL019 (tisagenlecleucel-T) as a new treatment for relapsed and refractory pediatric B-cell acute lymphoblastic leukemia. And on Monday preceding the panel review the FDA will be expected to deliver its internal review of the therapy, which will further tip its hand on what regulators are thinking about the data for a drug awarded its breakthrough therapy designation.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.