EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia

Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia and to the powder for oral suspension.

BMS has announced that the European Medicines Agency (EMA) has validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1-18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) and to include the powder for oral suspension. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

"Treatment options for pediatric patients with chronic phase CML, along with formulations that support the unique demands of children with cancer continue to be unmet needs," said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. "Building on our long-standing heritage in hematology, including the use of Sprycel for more than a decade to treat adults with certain forms of CML, the validation of this application supports our commitment to expand options for children and adolescents with different types of cancer."

The application includes data from CA180-226 (NCT00777036), an ongoing Phase II, open-label, non-randomized trial studying Sprycel in newly diagnosed chronic phase CML pediatric patients and in pediatric patients resistant to or intolerant of imatinib. Data from this study will be presented at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on Monday 5 June.