New orphan drug treats resistant leukemia

August 7, 2006

The Food & Drug Administration recently granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy-including imatinib (Gleevec, Novartis). The FDA also granted full approval to dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib, considered an orphan drug for each of these indications, is currently available in retail pharmacies.