FDA Approves Nelarabine Injection for the Treatment of T-ALL and T-LBL


The injectable formulation of nelarabine has been granted FDA approval to treatment 2 hematologic malignancies.

The FDA has granted approval to nelarabine injection for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).1

The approval of this therapy may provide an alternative to standard-of-care agents that currently have supply shortages, according to Shorla Oncology, developer of nelarabine.

“Successful treatment of children, adolescents, and young adults with cancer, such as children with T-cell acute lymphoblastic leukemia, is dependent on stable access to critical chemotherapy agents. Drug shortages directly impact patient outcome,” said Stephen P. Hunger, MD, chief of the Division of Oncology and Director of the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia, in a press release. “We are encouraged by the approval of Nelarabine Injection and the significant impact that we expect it will have on treatment access and patient care.”

According to a systematic review of data surrounding nelarabine, the treatment has a complete response rate of 37.2 (95% CI, 22.8-51.5) and a partial response rate of 10.2 (95% CI, 4.9-15.5).2

In terms of safety, the most common adverse events associated with nelarabine were neutropenia, thrombocytopenia, fatigue, infections, and reversible peripheral neuropathy.

“We are very proud to see our research in oncology innovation and dedication to patient care culminate in this US FDA approval,” said Sharon Cunningham, chief executive office and co-founder of Shorla Oncology, in the press release. “Nelarabine Injection is a critical treatment for patients living with T-cell Leukemia, particularly for children with leukemia, and it is our hope that today’s approval addresses the clinical need in this patient community.”


1. Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of t-cell leukemia. News release. Shorla Oncology. March 7, 2023. Accessed March 13, 2023. https://bwnews.pr/3mQJqXj

2. Kathpalia M Mishra P, Bahpai M, et al,. Efficacy and safety of nelarabine in patients with relapsed or refractory T-cell acute lymphoblastic leukemia: a systematic review and meta-analysis. Ann Hematol. 2022;101(8):1655-1666. doi: 10.1007/s00277-022-04880-1.

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