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

Mar 13, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in T-ALL.

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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

  1. Business Wire. Shorla oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. Published Mar 7, 2023. Accessed Mar 8, 2023.
  2. Litzow MR, Ferrando AA. How I treat T-cell acute lymphoblastic leukemia in adults. Blood. 2015;126(7):883-841. DOI: 1182/blood-2014-10-551895
  3. Cohen MH, Johnson JR, Justice R, et al. FDA drug approval summary: nelarabine (Arranon®) for the treatment of T-cell lymphoblastic leukemia/lymphoma. Oncologist. 2008;13(6)709-714. DOI: 1634/theoncologist.2006-0017
  4. Dunsmore KP, Winter SS, Devidas M, et al. Children's Oncology Group AALL0434: a phase III randomized clinical trial testing nelarabine in newly diagnosed T-cell acute lymphoblastic leukemia. J Clin Oncol. 2020;38(28):3282-3293. DOI: 1200/JCO.20.00256


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