ARTICLE | Clinical News

Blinatumomab regulatory update

October 13, 2014 7:00 AM UTC

FDA accepted and granted Priority Review to a BLA for blinatumomab to treat adults with Philadelphia-negative, relapsed/refractory B precursor acute lymphoblastic leukemia (ALL). The PDUFA date is May 19, 2015. Amgen also submitted an MAA to EMA in the indication, for which the compound has breakthrough therapy designation. The bispecific T cell engager (BiTE) against CD19 also has Orphan Drug designation in the U.S. and Europe to treat ALL, chronic lymphocytic leukemia (CLL) and indolent B cell lymphoma. Blinatumomab is in the Phase III E1910 trial to treat newly diagnosed BCR-ABL-negative ALL. ...