GSK files Atriance for blood cancers with EC

UK-based drug major GlaxoSmithKline says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) requesting approval for Atriance (nelarabine) as a treatment for T-cell acute lymphoblastic leukemia and lymphoma. Specifically, the firm is seeking authorization for the drug's use in children and adults with either condition, who have not responded to chemotherapy or have experienced relapse following two prior treatment regimen.

GSK's submission includes data from a trial of the Atriance carried out by the US National Cancer Institute's Children's Oncology Group. During the assessment the drug, which was administered intravenously to patients, brought about a complete response, including restoration of normal blood cell levels in 13% of those treated. A further 23% of subjects achieved a complete response without reaching normal blood cells levels.

In june of last year the EMEA granted nelarabine Orphan Drug designation which was followed by a similar decision from the US Food and Drug Administration later that year. The drug, which is known under the trade name Arranon in the USA, was launched in the country at the start of the year (Marketletter January 30),