Bristol-Myers announces EMA validation for Sprycel application
Bristol-Myers Squibb Company announced that the European Medicines Agency validated its grouped Type II variation/Extension of Application for Sprycel to treat children and adolescents aged one year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia 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. he application includes data from CA180-226, an ongoing Phase 2, 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, June 5.