UK drug giant GlaxoSmithKline has submitted an application to European regulators seeking approval to market Atriance for the treatment of adults and children with difficult-to-treat forms of leukaemia and lymphoma.
Specifically, the drugmaker is seeking clearance to treat patients with T-Cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) who have not responded to prior chemotherapy or have relapsed after two previous chemo regimens.
Both conditions are rare and predominantly occur in children. Due to the small population size of patients and the fact that these illnesses are particularly hard to treat, there is a high level of unmet need for effective treatment, the group notes. Consequently, Atriance (nelarabine) has been awarded Orphan status by the European Medicines Agency.
“The submission of nelarabine is an extremely important milestone for patients and physicians across Europe,” commented Paolo Paoletti, Senior Vice President of GSK’s Oncology Medicine Development Centre. “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.”
Earlier this year, the drug won clearance for the US market, where it is marketed as Arranon, for the treatment of T-ALL and T-BL, and it is also in development for other haematological cancers that could dramatically increase the number of patients eligible for treatment with the drug, and hike its sales potential up to around $500 million dollars a year, according to analysts.