Posted by Michael Wonder on 30 Aug 2018
U.S. Food and Drug Administration accepts Bristol-Myers Squibb’s application for Sprycel (dasatinib) in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
30 August 2018 - Application based on results from Phase 2 CA180-372 study.
Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license application for Sprycel (dasatinib) in combination with chemotherapy for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia.
The FDA action date is 29 December 2018.
