ARTICLE | Clinical News

Sprycel dasatinib regulatory update

November 1, 2010 7:00 AM UTC

FDA granted accelerated approval for an sNDA from Bristol-Myers for Sprycel dasatinib to treat newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase. As part of the approval, Bristol-Myers is required to collect additional long-term efficacy and safety data. ...