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FDA grants breakthrough therapy designation to JCAR015 for ALL
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The FDA granted breakthrough therapy designation to JCAR015, a chimeric antigen receptor-modified T-cell therapy candidate, for the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia who have not received prior therapy, according to the manufacturer.
Originally developed for treatment of patients with aggressive B-cell non-Hodgkin’s lymphoma, JCAR015 (Juno Therapeutics) is designed to target CD19, identified on most B-cell malignancies, including various subtypes of NHL and ALL.
“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,” Hans Bishop, CEO of Juno Therapeutics, said in press release.
The FDA based its decision in part on preliminary data from an ongoing phase 1 clinical study evaluating 22 adult patients with relapsed/refractory B-cell ALL, as well as data from a phase 1/2 study of six pediatric patients with ALL.