CAR-T, FDA

Novartis is keeping JULIET in hiding, but the FDA takes a peek and hands over a ‘breakthrough’ title

Vasant Narasimhan

There’s been considerable speculation of late about the data Novartis has collected from its JULIET study involving its closely-watched CAR-T drug. The pharma giant isn’t the best at communicating with the outside world and won’t say what it has seen so far or when exactly it will be put on display. But they have quietly given the FDA a peek, and regulators seem impressed.

In fact, the FDA has now handed over their breakthrough therapy designation for CTL019 as a new therapy for diffuse large B-cell lymphoma.

What’s the big deal?

BTDs are increasingly common, but this one is a bit different than your run-of-the-mill open door promise at the agency. While Novartis and Kite have been running neck and neck to get the first pioneering approval for a CAR-T, Novartis is taking its first shot at children with acute lymphoblastic leukemia while Kite shoots for DLBCL. Kite has put its DLBCL data up for the world to see, at 3 and 6 months, and now CAR-T observers want to see how they match up in the coming rivalry.

The FDA’s BTD indicates that Novartis has a good shot at it, but a tacit endorsement like this is no guarantee that CTL019 is any better than KTE-C19, also known as axi-cel. After all, the FDA already handed out breakthrough status to Kite’s drug for DLBCL, transformed follicular lymphoma and primary mediastinal b-cell lymphoma.

We’ll have to wait for an unspecified scientific conference to find out what Novartis has been keeping secret.

In the meantime Juno has been reorganizing its CAR-T R&D group, a story Endpoints News broke on Sunday evening, with the hire of Sunil Agarwal as the new head of research. Juno had to shelve its lead program after it killed 5 patients in clinical trials. The biotech has fallen more than a year behind the two leaders in the field.

Forbes‘ Matt Herper (left) with Sean Parker and Dr. Carl June (right) – screenshot


“We are encouraged by the FDA’s recognition in the potential of CTL019 for this indication, which follows our promising studies of this therapy for ALL and the FDA filing by Novartis in pediatric and young adult ALL that received priority review,” said Penn’s Carl June, director of the Center for Cellular Immunotherapies at the university’s Perelman School of Medicine.


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