FDA Approves New SPRYCELÃ (Dasatinib) Product Labeling For Patients With Chronic-Phase CML Part 3

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SPRYCEL and Escalated Doses of Gleevec (Study -017): The Phase 2 randomized, open-label study evaluate SPRYCEL 70 mg twice daily and Gleevec 800 mg (400 mg twice daily) in 150 patients with chronic-phase CML resistant to prior Gleevec dose of 400 or 600 mg. For patients receiving SPRYCEL, at 12 weeks 36 percent realize a middle cytogenetic answer, the study's opening endpoint (29 percent with Gleevec), and 22 percent achieved a through cytogenetic response (8 percent with Gleevec). With longer prone and follow-on, 52 percent achieved a major cytogenetic response (33 percent with Gleevec), and 40 percent of patients achieved a complete cytogenetic response (16 percent with Gleevec). The rate of major cytogenetic response with SPRYCEL was make ashamed among patients aged 65 years and over and done with.

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