GlaxoSmithKline's Atriance® (nelarabine) Receives Positive Opinion In Europe For The Treatment Of Rare, Difficult To Treat Leukaemias And Lymphoma

GlaxoSmithKline announced today that 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) patients whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.[1] Nelarabine will now be considered for final marketing approval by the European Commission.


"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," said Paolo Paoletti, SVP and Global Head of Oncology Research and Development, GSK. "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."


T-ALL and T-LBL are rare, difficult to treat forms of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL). There are only a few hundred cases of relapsed T-ALL each year in Europe.[2] Patients with T-ALL and T-LBL tend to have a worse prognosis than patients with B-cell disease. Given that there are few treatment options for those who do not respond to, or have relapsed following, at least two chemotherapy regimens, nelarabine is an important advance for this group of patients.


Nelarabine received EMEA orphan drug status in June 2005.[3] In the US, where nelarabine is marketed as Arranon® it received orphan drug status in December 2003 and FDA approval in October 2005.[4],[5]


The data submitted


The EMEA reviewed data from two, multi-centre pivotal Phase II clinical trials, both of which were conducted in collaboration with the National Cancer Institute (NCI) and published in Blood[6] and The Journal of Clinical Oncology.[7]


Adult patients


A Phase II study of adult patients with relapsed or refractory T-ALL or T-LBL was conducted to assess the efficacy and safety of nelarabine. 40 patients with relapsed or refractory T-ALL and T-LBL were enrolled, with 39 patients having received at least one dose of nelarabine. A subset of 28 patients out of 39, had relapsed following, or were refractory to, two or more prior chemotherapy treatments.6 Six patients (21%) had a complete response*with or without restoration of normal blood cell levels and one patient from this group went on to receive a stem cell transplant.8 A median overall survival of 20 weeks was reported.6















Paediatric patients


A Phase II study evaluated 153 paediatric patients (Buy Vasodilan Without Prescription