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U.S. Department of Health and Human Services

About FDA

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Dasatinib (Sprycel)

On October 28, 2010, the U. S. Food and Drug Administration granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb), an orally administered kinase inhibitor, for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (CP-CML). The recommended dasatinib dose for this indication is 100 mg orally once daily. Sprycel was originally approved in June 2006 for the treatment of adult patients with CP-CML resistant or intolerant to prior therapy that included imatinib.

The efficacy and safety of dasatinib in adults with newly diagnosed CP-CML were demonstrated in a single randomized, active-control, open-label multinational clinical trial. Five hundred and nineteen patients were randomized to receiver either dasatinib 100 mg QD (n = 259) or imatinib 400 mg QD (n = 260). The primary objective was to compare the rate of confirmed complete cytogenetic response (CCyR) by 12 months between the two treatment arms. Confirmed CCyR was defined as a CCyR noted on two consecutive occasions at least 28 days apart. The rate of major molecular response (MMR) at any time was a secondary endpoint. MMR was defined as BCR-ABL ratios
£ 0.1% by RQ-PCR in peripheral blood samples standardized on the International scale.

The primary efficacy endpoint, rate of confirmed CCyR by 12 months, was achieved in 199 patients (76.8%) and in 172 patients (66.2%) on the dasatinib and imatinib arms, respectively ( p= 0.007). The rate of MMR at any time was also higher in the dasatinib arm compared to the imatinib arm: 52.1% versus 33.8% in the dasatinib and imatinib groups, respectively (p < 0.0001).

Seventy-one percent of dasatinib treated patients compared to 78% of imatinib treated patients experienced at least one adverse drug reaction. Overall incidences of grade 3-4 toxicity were 7.8% among patients treated with dasatinib compared to 7.0% with imatinib. Common adverse reactions reported more frequently on the dasatinib arm compared to the imatinib arm include anemia, cough, dyspnea, headache, neutropenia, pleural effusion, and thrombocytopenia.

Full prescribing information is available at:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).