The approval is specifically for the 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.
“Arranon represents new hope for adults and children suffering from these rare and deadly cancers,” said Kevin Lokay, vice president of Oncology and Acute Care at GSK. “Arranon is an important milestone for our oncology business and provides a glimpse of our promise for the future.”
Arranon received accelerated approval, granted by the FDA to medicines for treating serious or life-threatening illnesses that address an unmet medical need, based on complete response rates demonstrated in two phase II trials in patients who had exhausted standard treatment options.
Post-marketing evaluation to verify and describe the product’s clinical benefit will be pursued through a randomized, multi-center phase III trial. The study will assess both event-free survival at four years and minimal residual disease in the post-consolidation phase for patients receiving standard therapy with or without Arranon.