Bristol-Myers Squibb received full approval from the FDA for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).

The full approval was based in part on results from a Phase III randomized, open-label dose-optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint was major cytogenetic response (MCyR), in Gleevec-resistant patients.

“Sprycel helps to fulfill a need for second-line treatments for CML patients with resistance or intolerance to Gleevec. The two-year follow-up data further support the use of Sprycel as an important treatment option for this patient population,” said Dr. Hagop Kantarjian, chairman and professor, Leukemia Department, M.D. Anderson Cancer Center.