Latebreakers: FDA approves lower dose of Sprycel

November 19, 2007

Lower dose of dasatinib (Sprycel) approved.

Bristol-Myers Squibb has been granted regulatory approval for a new indication for dasatinib (Sprycel). The agency nod provides for the use of a lower recommended starting dose of the drug for adult patients with chronic phase chronic myeloid leukemia (CML). According to the company, the new dose of 100 mg daily reduces the incidence of severe myelosuppression and fluid retention. Also, the product labeling will now include data from a phase II randomized trial of dasatinib and imatinib (Gleevec, Novartis) in patients with previously untreated chronic phase CML. Dasatinib, a kinase inhibitor, is also approved for the treatment of certain types of acute lymphoblastic leukemia.