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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

PARIS, June 15, 2012 /PRNewswire/ --

Results Presented at 17th Congress of the European Hematology Association

Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Europe Ltd., today announced six-year follow-up results from a Phase 3 randomised, open-label, dose-optimisation study of SPRYCEL® (dasatinib) in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients resistant or intolerant to Glivec® (imatinib).

Long-term survival data

The six-year data shows progression-free survival of 49.3% and an overall survival of 71% for patients randomised to dasatinib 100 mg once daily (n=167), with 6% of patients (n=10) progressing to accelerated or blast phase on study at six years of follow-up.[1]

Safety and tolerability data from patients randomized to the 100 mg arm during the six-year follow up are consistent with the previously reported safety profile of dasatinib 100 mg once daily. In this 100 mg QD arm, the most common grade 3/4 adverse events (AEs) were (cumulative 6 year occurrence): neutropenia (36%), thrombocytopaenia (24%), and anaemia (13%).[1] The cumulative incidence rates of the most common non-haematological AEs of Grade 3/4 at six years of follow-up were: diarrhoea (4.3%), fatigue (4.3%), infections (6.1%) and pleural effusion (5.3%).[2]

This is the longest reported follow-up of 2nd generation Tyrosine Kinase Inhibitors for patients resistant or intolerant to imatinib.

Safety and Tolerability at Six Years

Safety and tolerability data from the six-year study are consistent with the previously reported safety profile of dasatinib 100 mg once daily. For full information on
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SOURCE Bristol-Myers Squibb & Otsuka Pharmaceutical Europe Ltd.
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