Approval includes the first powder for oral suspension formulation of a tyrosine kinase inhibitor developed for administration in pediatric patients
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has expanded the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation. The approval follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use on April 26, 2018, and makes Sprycel the first ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in pediatric patients and patients who cannot swallow tablets.
The EC approval is based on data from CA180-226 (NCT00777036), the largest prospective 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.
“Treatment options for pediatric patients with CML are limited, as are formulations that correspond with the unique demands of children with cancer,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “Our decision to pursue an expanded indication for Sprycel in this new patient population and as a new formulation is indicative of our commitment to extending the potential of our medicines to address the unmet needs of patients with cancer, regardless of the incidence of the disease.”
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