Biotech upstart Juno Therapeutics has added an FDA "breakthrough" drug title to its considerable list of accomplishments, gaining regulators' commitment to hurry along a lead cancer program to a potential approval.
The FDA has added breakthrough boasting rights to JCAR015, one of three CAR-T therapies that Seattle-based Juno has been pushing along in the clinic less than a year after it launched. The designation comes just days after Juno, which has raised more than $300 million from investors, filed for an IPO.
The closely watched biotech quickly emerged as a leader in immuno-oncology, one of the hottest fields in drug development. Working with drugs that have been in development at Memorial Sloan-Kettering and the Fred Hutch, Juno's work centers on reengineering T cells with chimeric antigen receptors, making them targeted cancer cell killers. JCAR015 is in development for relapsed or refractory B-cell acute lymphoblastic leukemia.
In this case, breakthrough drug status can make an important difference for Juno, which is up against the pharma giant Novartis in pushing the first CAR-T drugs to the marketplace. Novartis is widely considered the leader in this race with a large program in place at Carl June's lab in the University of Pennsylvania.
|Dr. Richard Pazdur|
Dr. Richard Pazdur, who runs the FDA's oncology group, was an early and enthusiastic proponent of the FDA's breakthrough drug designation, helping to carve months away from development timelines of the most promising new cancer therapies as biopharma companies raced ahead with new studies that blur the lines between the different clinical challenges faced by an experimental medicine. New cancer drugs like this are going through adaptive studies that look early for efficacy data and often shoot for regulatory approval with midstage results.
- here's the release