GlaxoSmithKline applies for rare cancers drug approval

GlaxoSmithKline (GSK) has submitted a marketing authorisation application to the European Medicines Agency (EMEA) for Atriance (nelarabine), a treatment for T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

Atriance is a therapy targeted at adults and children with the diseases who have not responded to chemotherapy, or in cases where the disease has relapsed following two or more courses of chemotherapy.

One clinical trial involved 39 patients with T-ALL or T-LBL, of whom 28 had relapsed after two or more courses of chemotherapy. Of the 28, the number of patients achieving a complete response – the disappearance of disease symptoms – was18 per cent, while 21 per cent achieved a complete response with or without the restoration of blood cell levels.

Paolo Paoletti, senior vice president of oncology medicine development, said: “The submission of nelarabine is an extremely important milestone for patients and physicians across Europe.

“Rare cancers such as T-ALL and T-LBL are often overlooked in terms of clinical research and development, and GSK’s work towards bringing this important therapy to market underscores our commitment to all cancer patients around the world, no matter how rare and difficult to treat their disease may be.”

Dr Paoletti concluded: “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 diseases are described as rare conditions. T-ALL accounts for between a fifth and a quarter of acute lymphoblastic leukaemia cases – a disease caused by the overproduction of a cancerous type of white blood cell.

T-LBL is a rare type of lymphoblastic lymphoma, a cancer affecting the body’s lymphatic system. This variant of the disease accounts for less than three per cent of cases.

GSK says that the rare nature of the diseases means that there is a “high level of unmet clinical need”.

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