FDA grants priority review to Sprycel for newly diagnosed chronic myeloid leukemia (CML) in chronic phase

Bristol-Myers Squibb and Otsuka announced that 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 has been accepted for filing and granted priority review by the FDA. The filing is based on the results of the DASISION trial. Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from ten to six months.

Sprycel is an oral BCR-ABL inhibitor currently approved for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib; as well as adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

For more information call (800) 321-1335 or visit www.SPRYCEL.com.