GSK is seeking US approval of Arranon for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
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.
“Today’s decision brings us one step closer to fulfilling our company’s commitment to providing a new treatment option for these patients suffering from a rare and deadly disease,” said Dr Paolo Paoletti, senior vice president of the oncology medicine development center, at GSK.
In December 2003, the FDA granted Arranon Fast Track designation, conferred on products in development that demonstrate a potential to address an unmet medical need for a serious or life-threatening condition.
The FDA later granted Arranon orphan drug status, a designation given to products under development for a rare disease or condition termed as a diseease affecting fewer than 200,000 people per year in the US. It is estimated that 1,600 adults and children are diagnosed in the United States every year with these rare cancers, T-ALL and T-LBL.