Posted by Michael Wonder on 20 May 2017
European Medicines Agency validates application for Bristol-Myers Squibb’s Sprycel (dasatinib) in children with chronic myelogenous leukaemia
19 May 2017 - Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia and to the powder for oral suspension.
Bristol-Myers Squibb Company today announced that the EMA 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 leukaemia and to include the powder for oral suspension.
Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.
