GlaxoSmithKline plc (GSK) announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) seeking marketing approval for ATRIANCE (nelarabine)

04-13-2007

GlaxoSmithKline plc (GSK) announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) seeking marketing approval for ATRIANCE (nelarabine) injection to treat adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to chemotherapy or has relapsed following at least two previous chemotherapy regimes.

"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," commented Paolo Paoletti, MD, senior vice president, Oncology Medicine Development Centre, GSK. "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 T-ALL and T-LBL are rare conditions, which both predominantly occur in children. T-ALL is a form of acute lymphoblastic leukaemia and accounts for about 20 to 25% of acute lymphoblastic leukaemia cases (4.75 per 100,000 people). T-LBL is a rare form of lymphoblastic lymphoma which accounts for less than 3 in 100 cases overall. Due to the size of this patient population and the fact that these diseases are very difficult to treat, there remains a high level of unmet need for effective treatment options.

In a pediatric trial performed by the U.S. National Cancer Institute (NCI) Children's Oncology Group, nelarabine was administered intravenously to patients under the age of 21 with relapsed or refractory T-ALL or T-LBL. Of the 39 patients who had received two or more prior induction regimens, 13% achieved a complete response and 23% achieved a complete response with or without restoration of normal blood cell levels.

The safety and efficacy of nelarabine was evaluated in a phase II clinical trial performed by the U.S. NCI Cancer and Leukemia Group B (CALGB) which included 39 adults (aged between 16 to 65 years of age, mean 34 years) with T-ALL or T-LBL, 28 of whom had relapsed or were refractory to at least two prior induction regimens. Eighteen percent of these 28 patients treated with nelarabine achieved a complete response, and 21% of patients achieved a complete response with or without restoration of normal blood cell levels. Both of these studies were sponsored by the NCI under a Clinical Trials Agreement between the NCI and GSK.

The principle dose-limiting side effect in pediatric patients was neurological. Thirty-two subjects (38%) reported at least one neurologic event, including Grade 3 or 4 peripheral neuropathy. The most common adverse events, regardless of causality, were hematologic disorders (anemia, leukopenia, neutropenia, and thrombocytopenia). ;

The EMEA granted Orphan Drug status to nelarabine in June 2005. The U.S. Food and Drug Administration (FDA) granted marketing approval for nelarabine in October 2005 under the trade name of Arranon, which was then launched in the United States in January 2006.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.