FDA Approves Dasatinib for Pediatric Ph+ Chronic Phase CML

November 10, 2017 – The FDA has approved dasatinib for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). The approval is based on results with dasatinib demonstrated in 97 pediatric patients with CP-CML enrolled across 2 studies, an open-label, nonrandomized, single-arm phase II trial (CA180-226; NCT00777036) and an open-label, nonrandomized, dose-ranging phase I trial … (leggi tutto)