GlaxoSmithKline’s Atriance® (nelarabine solution for infusion) has received a positive opinion from the European Medicines Agency (EMEA) for the treatment of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.
Atriance® is now being considered for final marketing approval by the European Commission for these difficult to treat forms of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL): T-ALL and T-LBL.
According to Paolo Paoletti, SVP and Global Head of Oncologylinks Research and Development, GSK:
“Nelarabine may offer some patients the chance to go on to have potentially curative treatment, such as a stem cell transplant, so we are delighted that nelarabine has been granted a positive opinion from the EMEA.
We are immensely proud of our involvement in the development of this orphan drug for such a rare disease, and believe it is an excellent example of our long-term commitment to improving the lives of patients through our ongoing investment in R&D – be they in their tens of thousands or, as in this case, as few as hundreds.”
In the U.S., Atriance® (nelarabine) is marketed as Arranon®: it received orphan drug status in December 2003 and FDA approval in October 2005.
The EMEA on the other hand, granted orphan drug status in June 2005 to Atriance® (nelarabine).