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Six-Year Follow-Up Data for SPRYCEL®? (dasatinib) 100 mg Once Daily Demonstrates 71 Percent Overall Survival in Patients with Chronic-Phase Chronic Myeloid Leukaemia Resistant or Intolerant to Imatinib
Date:6/15/2012

SPRYCEL (dasatinib) please refer to SmPC at http://www.ema.europa.eu/.

These data were presented today at the 17th Congress of the European Hematology Association in Amsterdam. (Poster 0199).

About Study CA180-034

Study CA180-034 was designed to assess the efficacy and safety of dasatinib following intolerance or resistance to imatinib. The trial enrolled 670 CP-CML patients with resistance (n=497) or intolerance (n=173) to imatinibwho were randomised to one of four treatment arms: 100 mg once daily (n=167), 50 mg twice daily (n=168), 140 mg once daily (n=167) and 70 mg twice daily (n=168). In this pre-treated population, the median time from onset of CML to randomisation in patients on the 100 mg once daily arm was 55 months and 46% of these patients had more than three years of prior imatinib treatment. Data on the primary endpoint of the study, major cytogenetic response with a minimum follow up of 6 months in imatinib-resistant patients, have been previously reported. Thirty-one percent of patients randomised to receive dasatinib 100 mg once daily remained on treatment at 6 years.[1]

About SPRYCEL®

Discovered and developed by Bristol-Myers Squibb, dasatinib was initially approved by the FDA and the European Commission in 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including imatinib and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) intolerant or resistant to prior therapy. In the U.S., dasatinib received accelerated FDA approval for this indication. Since then, dasatinib has been approved for this indication in more than 60 countries worldwide.

In 2010, dasatinib 100 mg once daily was approved by the FDA and European Commission for the treatment of adult patients with newly di
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SOURCE Bristol-Myers Squibb & Otsuka Pharmaceutical Europe Ltd.
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