Fast Approval: Dasatinib for Leukemia

The FDA has granted accelerated approval for dasatinib (Sprycel, Bristol-Myers Squibb), a new oral treatment for patients with chronic myeloid leukemia (CML). CML is a rare cancer that is characterized by the uncontrolled growth of white blood cells. CML affects about 4,600 people annually in the U.S.

The FDA has also given regular approval to this drug for use in the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), a more serious form of leukemia. Both approvals are for patients who have experienced resistance or intolerance to prior therapy.
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Dasatinib is indicated for patients with CML who are no longer responding to, or who can no longer tolerate, therapy with imatinib mesylate (Gleevec, Novartis), which was approved in 2001. It works by reducing the activity of one or more proteins responsible for the uncontrolled growth of the leukemia cells.

Dasatinib is considered an orphan drug for these indications. Its approval was based on evidence from four single-arm studies in more than 400 patients.