Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for SPRYCEL® (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase. The companies also announced today that the application has been granted a priority review designation by the FDA. Based on FDA's six month goal for completing priority reviews, the projected FDA action date is October 28, 2010. The filing is based on the results of the DASISION trial.
Bristol-Myers Squibb Company