Additionally, BMS and Otsuka Pharma have received a priority review designation from the FDA for the sNDA.
Sprycel, an oral BCR-ABL inhibitor, is currently approved by the FDA for the treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).
Sprycel is also approved for the treatment of adults with Philadelphia chromosome acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Sprycel’s active ingredient is dasatinib. At nanomolar concentrations, dasatinib reduces the activity of one or more proteins responsible for the uncontrolled growth of the leukemia cells of patients with CML or Ph+ ALL.
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, a study comparing the investigational use of Sprycel versus Gleevec as a first-line treatment for patients with chronic phase CML-CP.