ARTICLE | Company News

Speedy approval for Amgen's Blincyto

December 4, 2014 2:58 AM UTC

FDA granted accelerated approval to Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) to treat Philadelphia chromosome-negative precursor B cell acute lymphoblastic leukemia (ALL), well ahead of its May 19, 2015 PDUFA date. The agency accepted a BLA for the drug and granted it Priority Review on Oct. 9.

Blincyto has breakthrough therapy designation for its approved indication, and has Orphan Drug designation in the U.S. and EU to treat ALL, chronic lymphocytic leukemia (CLL) and indolent B cell lymphoma. It also is under EMA review. ...