Research & Development
Sprycel for CP-CML Now Includes Pediatric Indication in Europe
10 July 2018 - - New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) was approved by the European Commission (EC) to expand the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged one year to 18 years with Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) in chronic phase, and to include a powder for oral suspension formulation, the company said.
The EC approval is based on data from the CA180-226 trial evaluating the safety and efficacy of Sprycel in pediatric patients newly diagnosed with CP-CML, and in those resistant to or intolerant of imatinib.
In the trial, patients with CP-CML resistant to or intolerant of imatinib who received Sprycel demonstrated a cumulative major cytogenetic response rate of 55.2% three months into treatment, exceeding the defined threshold of clinical interest for the primary endpoint of the cohort and increasing over time to greater than 90% at 24 months.
Newly diagnosed patients with CP-CML who received Sprycel achieved a cumulative complete cytogenetic response rate of 64% as early as six months into treatment, exceeding the defined threshold of clinical interest and increasing over time to 94% at 24 months.
The secondary endpoint of estimated progression-free survival at 48 months was greater than 75% for patients resistant to or intolerant of imatinib and greater than 90% for patients who received Sprycel as a first-line therapy.
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