GSK’s leukaemia drug closer to European approval
pharmafile | June 28, 2007 | News story | Sales and Marketing |Â Â Â
GlaxoSmithKline's orphan leukaemia treatment Atriance has been recommended for European approval by a key EMEA committee.
Atriance (nelarabine) was given a positive opinion by the EMEA's Committee for Medicinal Products for Human Use based on clinical trial results in which some patients were subsequently able to receive a stem cell transplant.
Paolo Paoletti, SVP and Global Head of Oncology Research and Development at GSK, said: "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."
The CHMP recommended Atriances approval to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) patients whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.
The diseases are rare and difficult to treat and patients tend to have a worse prognosis than those with the more common B-cell disease. There are only a few hundred cases of relapsed T-ALL each year in Europe and there are few treatment options for either it or T-LBL.
In a phase II trial of 40 adult patients with T-ALL or T-LBL, six had a complete response, one of which went on to receive a stem cell transplant. A phase II paediatric study involving 153 patients saw nine experience a complete response and four receive a stem cell transplant.
The most common side effects during therapy with Atriance included haematologic (blood) toxicity, fatigue, and nausea. Severe neurological events have also been reported with its use.
Atriance received FDA approval in October 2005 and is marketed in the US as Arranon. GSK and GSK has filed the drug with regulators in Canada, Japan, Switzerland and Israel.
