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.

The latest twist in this closely-watched saga comes a little more than two months since Novartis won a priority review for its potentially revolutionary CAR-T, which extracts T cells from patients, reengineers them and infuses them by the millions to swarm cancer cells. The priority review lopped two months off the review process, hitting fast forward on the agency’s call.

Right on its heels, two months behind in the process, is Kite Pharma $KITE with its application to market KTE-C19 (axicabtagene ciloleucel) for non-Hodgkin lymphoma, also newly offered a priority review of its own.

Novartis and Kite have both offered some compelling data for these CAR-Ts. And while they are not currently going head-to-head on the same indication, Novartis will be offering what could be a direct challenge when it rolls out its JULIET data mid-week.

I’ll be following that too.

In addition to efficacy, you can expect plenty of discussion about the safety profile of this drug. Unlike its rivals, Novartis and its partners at the University of Pennsylvania have largely avoided the safety crises that afflicted Juno $JUNO and blew up its lead therapy. Kite also has had to deal with the death of one patient from a case of cerebral edema while cytokine release syndrome continues to hover as clear threat that physicians have to guard against in many cases.

If approved, Novartis will also be expected to compete effectively on the manufacturing side, working to reduce the time it takes to get this drug from patients, prepare it and then get it back into the vein.

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