Sprycel gets expedited approval for CML

US drug major Bristol-Myers Squibb says that the Food and Drug Administration has granted accelerated approval for Sprycel (dasatinib), the firm's developmental treatment for chronic myeloid leukemia. Specifically, the approval relates to the product's use in the treatment of CML patients who are resistant or intolerant to other therapies, including Novartis' Gleevec (imatinib mesylate). In addition, the FDA approved the drug's use in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia.

Sprycel is an oral tyrosine kinase inhibitor, which is thought to target enzymes involved in the production of leukemic white blood cells that characterize the condition. In doing so, the drug is believed to allow normal levels of red and white blood cell and platelet synthesis to take place.

B-MS added that the FDA approval of the drug is based on hematologic and cytogenetic response rates, as there were no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.