Posted by Michael Wonder on 02 Jan 2019
Bristol-Myers Squibb’s Sprycel (dasatinib) tablets now approved in combination with chemotherapy in certain paediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia
2 January 2018 - Approval marks second paediatric leukaemia indication for Sprycel.
Bristol-Myers Squibb today announced the U.S. FDA has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of paediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia in combination with chemotherapy. Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population.
The approval, which was granted following priority review by the FDA, is based on data from the Phase 2 study, CA180-372 (NCT01460160).
