GlaxoSmithKline has announced the accelerated approval of nelarabine (Arranon®) Injection by the FDA. This chemotherapy agent is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma 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. Randomized trials demonstrating increased survival or other clinical benefits have not been conducted. Postmarketing evaluation will be pursued though a randomized, multi-center, phase 3 trial.
In December 2003, nelarabine received a “fast track” designation and was later granted orphan drug status. In September 2005, the FDA’s advisory committee voted to recommend that the FDA grant accelerated approval of nelarabine for both children and adults.