GSK's Atriance approved by EC

UK drug major GlaxoSmithKline's Atriance (nelarabine solution for infusion) has received approval from the European Commission for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens. The approval is based on data from two, multicenter pivotal Phase II trials. In one of these studies, adults with relapsed or refractory T-ALL or T-LBL, six out of a subset of 28 patients, had a complete response with or without restoration of normal blood cell levels, while one received a stem cell transplant.