GSK submits European MAA for cancer treatment

GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Atriance (nelarabine) injection to treat adults and children with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

The treatment would only be for patients whose disease has not responded to chemotherapy or has relapsed following at least two previous chemotherapy regimes.

Paolo Paoletti, senior vice-president, Oncology Medicine Development Centre, GSK said: "Patients with these forms of cancer have limited treatment options and nelarabine may offer new hope for T-ALL and T-LBL patients who have not had successes with previous chemotherapy."

Both T-ALL and T-LBL are rare conditions, which both predominantly occur in children. T-ALL is a form of acute lymphoblastic leukaemia and accounts for about 20% - 25% of acute lymphoblastic leukaemia cases (4.75 per 100,000 people). T-LBL is a rare form of lymphoblastic lymphoma which accounts for less than 3 in 100 cases overall.

The EMEA granted Orphan Drug status to nelarabine in June 2005. The US Food and Drug Administration granted marketing approval for nelarabine in October 2005 under the trade name Arranon, and it was launched in the US in January 2006.