CML-CPChronic Myelocytic Leukemia Cells in Chronic Phase
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The approval was based on two prospective studies of nilotinib in children with Ph+ CML-CP, which were part of a formal paediatric investigation plan agreed upon with the EMA.
These pediatric patients were aged 2 to 18 years and diagnosed with either newly diagnosed Ph+ CML-CP or Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.
About 33-year-old, diagnosed case of CML-CP, started on Imatinib 400 once daily as first-line treatment.
Bristol-Myers Squibb and Otsuka are in the process of submitting the DASISION data to worldwide health authorities this year for the approval of SPRYCEL as a first-line treatment for newly diagnosed adult patients with CML-CP.
The trial enrolled 670 CML-CP patients with resistance (n=497) or intolerance (n=173) to Gleevec who 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).