14 DAY TRIAL // GlaxoSmithKline announced that the Oncologic Drugs Advisory Committee to the United States Food and Drug Administration recommended the accelerated approval of Arranon (nelarabine) Injection, a chemotherapy agent.
Discovered by GSK, Arranon is a water-soluble prodrug of ara-G with T-cell selectivity.
GSK is seeking approval in the United States of Arranon for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
It is estimated that 1,600 adults and children are diagnosed in the United States only, every year, with these rare cancers, T-ALL and T-LBL.
By a vote of 11 to 1, the advisory committee recommended that accelerated approval be granted in the pediatric population.
The committee was unanimous in recommending accelerated approval for the adult population.