GlaxoSmithKline Announces Approval of ARRANON(R) (nelarabine)

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has approved ARRANON(R) (nelarabine), a chemotherapy agent, treating patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses.

Approximately 1,600 adults and children are diagnosed with T-ALL or T-LBL in the U.S. each year. Some of these patients will relapse or develop disease that is not responsive to treatment. There is no standard of treatment for these patients and their prognosis is particularly poor. To facilitate the development of ARRANON for this relatively small group of patients, GSK worked closely with the National Cancer Institute (NCI) of the National Institutes of Health (NIH), the Children's Oncology Group (COG) and the Cancer and Leukemia Group B (CALGB), in conjunction with the Southwest Oncology Group (SWOG).