FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. 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 I clinical trials are currently underway.

JCAR015 is currently being tested in clinical trials at Seattle Children’s Hospital for relapsed/refractory CD19-positive pediatric leukemia and at Fred Hutchinson Cancer Research Center for refractory chronic lymphocytic leukemia, non-Hodgkin lymphoma, and acute lymphoblastic leukemia. Data on these programs will be presented at the 54th Annual Meeting of the American Society of Hematology meeting next week in San Francisco.

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. ■




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