Leukemia :: GSK’s Atriance, nelarabine for leukaemias and lymphomas approved in Europe

GlaxoSmithKline announced that Atriance? (nelarabine solution for infusion) has received approval from the European Commission for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.

?The approval of nelarabine for this orphan indication, addresses the real patient need that exists in these rare types of leukaemia and lymphoma?, said Andrew Witty, President, European Pharmaceuticals, GlaxoSmithKline.

?Full development for nelarabine began in the 1990’s and it has taken over a decade of GSK development and participation in innovative collaborations with well recognised organisations such as the National Cancer Institute (NCI) in the U.S. to provide the data to bring this product to market in Europe.?

There are only a few hundred patients diagnosed with relapsed/refractory T-ALL/T-LBL each year in Europe and patients with T-ALL and T-LBL tend to have a worse prognosis than patients with B-cell disease.

“This is a significant and important approval for those patients affected and their specialist physicians across Europe. Nelarabine 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. ?Many therapies currently used are combinations of cytotoxic drugs which can have a high rate of toxicity. Nelarabine given as a single drug has shown activity and a predictable side-effect profile, and the way it is administered means some patients are able to return home between cycles.?

The approved indication for nelarabine is based on data from two, multi-centre pivotal Phase II clinical trials, both of which were conducted in collaboration with the NCI in the U.S.and published in Blood and The Journal of Clinical Oncology respectively.


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