FDA Accepts Application for Dasatinib for Pediatric Ph+ ALL

August 30, 2018 – The FDA has accepted a supplemental biologics license application (sBLA) for dasatinib for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL). The sBLA is supported by data from the phase II CA180-372 (NCT01460160) trial, in which pediatric patients with newly diagnosed Ph+ ALL received dasatinib added to … (leggi tutto)