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Dasatinib And Nilotinib Now Frontline Treatment For Chronic Myelogenous Leukemia
December 11, 2007 at 3:14 PM
Drug News
All patients in both trials have a complete cytogenetic response - absence of the aberrant chromosome that causes the disease - after one year on either drug. Approximately 90 percent reach complete cytogenetic response as early as 6 months.
"These are early results but certainly encouraging so far in both cases," says lead author Jorge Cortes, M.D., professor in M. D. Anderson's Department of Leukemia. Patients in both trials are in the chronic, or initial phase, of CML and had not received prior therapy for their disease.
The two medications are dasatinib, the Bristol-Myers Squibb drug known as Sprycel(r), and nilotinib, the Novartis drug known as Tasigna(r). Both have been approved by the U.S. Food and Drug Administration for use in CML patients whose disease becomes resistant to the frontline therapy imatinib, also a Novartis drug known as Gleevec(r), or who become intolerant to the drug.
Cortes and colleagues compared the two medications at 3, 6 and 12 months with historical data from patients who took either 400 mg or 800 mg daily of Gleevec.
For dasatinib, at three months 26 of 33 patients (79 percent) achieved complete cytogenetic response. At six months 30 of 32 (94 percent) and at 12 months all 24 evaluable patients were at a complete cytogenetic response.
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