FDA Approvals in CML, CTCL, CMV Infection, and Tumor Assay, and Clinical Holds Lifted

November 20, 2017 – The FDA has approved dasatinib for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. The approval is based on results in 97 pediatric patients with CP-CML enrolled across 2 studies with dasatinib. One was an open-label, nonrandomized, single-arm phase II trial and the other was an open-label, nonrandomized, dose-ranging phase I trial. In the single-arm trial, 51 patients were … (leggi tutto)