Nelarabine injection receives U.S. FDA approval for the treatment of T-ALL and T-LBL

On March 7, 2023, it was announced that nelarabine injection, a prodrug of guanine arabinoside, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma.^1,2

This approval is encouraging for pediatric and young adult patients with T-ALL who have not responded to, or have relapsed following, treatment with prior chemotherapeutic agents, addressing a clinical need in this patient group.³

T-ALL is a rare and aggressive subtype of ALL which is most common in children.¹ Currently, nelarabine is the only approved treatment for T-ALL in both pediatric and adult patients. The phase III COG AALL0434 trial (NCT00408005) investigating nelarabine and escalating-dose methotrexate in young patients with newly diagnosed T-cell ALL or T-cell lymphoblastic lymphoma, previously reported on the ALL hub, demonstrated promising 5-year survival outcomes; event-free survival, overall survival, and disease-free survival was 88%, 90%, and 91%, respectively.⁴