GSK receives European approval for Atriance
29 August 2007 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline (GSK) has announced that it has received approval from the European commission for Atriance (nelarabine solution for infusion) as a treatment for patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).
The compound has been approved for use in patients whose disease has relapsed or not responded to previous treatment of a minimum of two regimens of chemotherapy.
Patients with relapsed or refractory T-ALL and T-BL will often have a worse prognosis than patients with B-cell disease, the company notes.
Approval of Atriance is based on data from two key phase II clinical trials published in Blood and the Journal of Clinical Oncology.
Professor Dieter Hoelzer, from J W Goethe University in Germany, said: "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."
He added that at present, patients are often treated with therapies containing a combination of potentially toxic cytotoxic drugs, while nelarabine offers patients a predictable profile of adverse effects.
In June 2007, GSK reported that it was "immensely proud" of the development of Atriance as a treatment of the rare condition, which sees only a few hundred new diagnoses in Europe every year.
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