Posted by Michael Wonder on 10 Jul 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Sprycel (dasatinib) in children with Philadelphia chromosome positive chronic phase chronic myeloid leukaemia
10 July 2017 - Application is based on results from Phase 2 CA180-226 study.
Bristol-Myers Squibb Company today announced that the U.S. FDA accepted its supplemental new drug application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukaemia, as well as a powder for oral suspension formulation of Sprycel.
The application is under priority review with an action date of November 9, 2017.
