J&J CAR T nabs accelerated review status in U.S. for multiple myeloma

The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals’ CAR T candidate JNJ-682284528 (JNJ-4528) a Breakthrough Therapy for the treatment of relapsed/refractory multiple myeloma.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3524575-j-and-j-car-t-nabs-accelerated-review-status-in-u-s-for-multiple-myeloma