On June 28, 2006, the U.S. Food and Drug Administration approved dasatinib (Sprycel; Bristol-Myers Squibb), a new small-molecule inhibitor of multiple tyrosine kinases, for the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) with resistance or intolerance to prior therapy including imatinib. The approval was based on four single-arm multicenter studies that combined 445 patietns and supported the efficacy and safety of dasatinib.
The FDA approval was for newly diagnosed patinets; however, there is evidence that Sprycel is effective in patients who fail imatinib as well. Study CALGB 180-034 was designed to assess the efficacy and safety of dasatinib following intolerance or resistance to imatinib. With six years fo followup, thirty-one percent of patients randomised to receive dasatinib 100 mg once daily remained on treatment. There was progression-free survival of 49.3% and an overall survival of 71% for with 6% of patients (n=10) progressing to accelerated or blast phase on study at six years of follow-up. Common toxicities with dasatinib included myelosuppression, bleeding, and fluid retention.
For Professional version see here