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GSK's Atriance approved in EU

The EU Commission has approved GlaxoSmithKline's leukaemia drug Atriance for the treatment of  T-cell acute lymphoblastic leukaemia and lymphoma patients unresponsive to previous chemotherapy

The EU Commission has approved GlaxoSmithKline's (GSK's) leukaemia drug Atriance (nelarabine) for the treatment of  T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) patients whose disease has not responded to, or has relapsed following treatment with at least two chemotherapy regimens.

"This is a significant and important new licence for those patients affected and their specialist physicians across Europe. Atriance may offer a valuable chance for patients with few existing treatment options to go on to have potentially curative treatment, such as a stem cell transplant", said Professor Dieter Hoelzer, from J.W.Goethe Universit‰t, Germany.

Trial results
The efficacy and safety profile of Atriance were evaluated in two, multi-centre pivotal Phase II clinical trials - one conducted in adults and one in children with refractory or relapsed T-ALL or T-LBL.

Both trials were carried out in the US in collaboration with the National cancer Institute (NCI) and published in Blood and The Journal of Clinical Oncology respectively.

The studies found that around 20 per cent of patients who received Atriance according to the licensed dosage and who had relapsed following, or were refractory to, two or more prior chemotherapy regimens, experienced a complete response, with or without restoration of normal blood cells levels.

The European Medicines Agency (EMEA) gave Atriance a positive opinion in June 2007.

 

30th August 2007

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