BioCentury
ARTICLE | Clinical News

Blincyto blinatumomab regulatory update

October 5, 2015 7:00 AM UTC

EMA’s CHMP recommended conditional approval of Blincyto blinatumomab from Amgen to treat adults with Philadelphia-negative (Ph-), relapsed or refractory, B precursor acute lymphoblastic leukemia (ALL). Amgen expects a decision from the European Commission in the “coming months.” The application is based on data from the Phase II MT103-211 and MT103-206 trials (see BioCentury, May 1, 2012 & June 2, 2014). ...