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

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.

Endpoints News

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.