Nov 24, 2014
Juno T Cell Therapy For Leukemia Granted FDA Breakthrough Therapy Designation
EATTLE, Nov. 24, 2014 /PRNewswire/ -- Juno Therapeutics today announced that the FDA has granted Breakthrough Therapy Designation to the company's JCAR015 chimeric antigen receptor product candidate. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was filed by Juno's collaboration partner, Memorial Sloan Kettering Cancer Center, where Phase 1 clinical trials are currently underway.
"The FDA's action is important news for patients who may benefit from the accelerated development of JCAR015 and is an important moment for the field of cancer immunotherapy, which has the potential to meet the need for more effective treatments in a range of cancers," said Juno CEO Hans Bishop.
The FDA's Breakthrough Therapy Designation was created to help accelerate the development and review of new drugs for serious or life-threatening conditions. The designation comes with potential benefits, including intensive FDA guidance and eligibility for priority review. It is granted to applicants whepreliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinical endpoints
"The interim analysis of this study, and results of our prior phase 1/2 study, have shown that a single dose of NurOwn™ is safe and can provide clinically meaningful benefits to ALS patients, such as a reduction in the rate of progression, and in some patients, actual improvements in function," Fiorino continued.
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