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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GSK Arranon to launch in early 2006: GlaxoSmithKline's leukemia and lymphoma therapy Arranon (nelarabine) will debut early next year following accelerated approval Oct. 28. The orphan drug is indicated for "treatment of 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." Approval of the "last resort" chemotherapy was based on two open-label, single-arm Phase II trials that showed complete disappearance of cancer cells in nine (23%) of the 39 pediatric patients treated and six (21%) of the 28 adults studied, FDA says. Complete disappearance of cancer cells lasted from 3.3 to 9.3 weeks in pediatric patients and from 4 to 195 weeks in adults. GSK will conduct a Phase III confirmatory study to fulfill its accelerated approval requirement...

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