All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know ALL.

The ALL Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
  TRANSLATE

The ALL Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the ALL Hub cannot guarantee the accuracy of translated content. The ALL Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2023-03-13T15:47:55.000Z

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

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

Bookmark this article

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. https://www.businesswire.com/news/home/20230307005479/en/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

Newsletter

Subscribe to get the best content related to ALL delivered to your inbox