Amgen's Blincyto gets expanded label, full FDA approval in ALL

Amgen Inc. (NASDAQ:AMGN) said FDA granted full approval to Blincyto blinatumomab (AMG 103) to treat relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). Since 2014, Blincyto had accelerated approval to treat Philadelphia chromosome-negative (Ph-) relapsed or refractory B cell precursor ALL.

Blincyto's label will include data from the Phase III TOWER trial, in which Blincyto significantly improved overall survival (OS) vs. standard of care in the indication for which it had accelerated approval. Blincyto had gained that approval based on tumor response rates in an earlier study (see BioCentury, June 20, 2016)...