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EMA Validates Application For Bristol-Myers' Sprycel In Children With CML

Bristol-Myers Squibb Co. (BMY) said that the European Medicines Agency validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia or 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.

The application includes data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel innewly 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.

by RTT Staff Writer

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