13 August 2015 - Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib monohydrate) product labeling. The labeling now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant1 or intolerant2 to prior therapy, including Gleevec/Glivec (imatinib mesylate).

“The five- and seven-year data now included in the Sprycel U.S. label offer valuable insight into its long-term efficacy and safety profile in both first- and second-line patients,” said Neil Shah, MD, PhD, Associate Professor, Division of Hematology/Oncology, University of California, San Francisco. “CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Given the chronic nature of CML, these long-term data are particularly important for patient care.”

For more details, go to: http://news.bms.com/press-release/fda-approves-us-product-labeling-update-sprycel-dasatinib-include-five-year-first-line