FDA Clears Larger Vial Size of Nelarabine Injection in T-ALL and T-LBL

The FDA has granted approval to a larger vial size of nelarabine injection (SH-111) for use in treatment of adult and pediatric patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).¹

Nelarabine injection is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients aged 1 year and older with relapsed or refractory (R/R) disease following treatment with at least 2 chemotherapy regimens. This approval marks the agent’s second FDA approval after its initial approval in 2023 for a 250-mg/50-mL–sized vial.

According to developer Shorla Oncology, the introduction of the larger vial aims to address real-world clinical needs, particularly the differing dose needs between adult and pediatric patients. Retaining the same formulation, the new vial size of 375 mg/75 mL promises to offer more precise and flexible dosing options for both age groups with fewer vials, thereby allowing more individualized treatment while reducing vial waste.

“Launching nelarabine injection as our first product in the US was a major milestone. Expanding that footprint with a 375[-]mg vial of nelarabine injection reflects our ongoing commitment to solving real-world challenges for patients with T-cell leukemia by prioritizing improvements in healthcare delivery, pharmacy workflow, and waste reduction,” said Orlaith Ryan, chief technology officer and co-founder of Shorla Oncology, in a news release.¹ “This additional vial size strengthens our ability to support both clinicians and patients living with T-ALL and T-LBL, where flexibility and accuracy in dosing is important.”

About Nelarabine and Clinical Data

The intravenous administration of nelarabine (Arranon) was granted accelerated approval from the FDA in 2005 for treatment of patients with R/R T-ALL and T-LBL following treatment with at least 2 chemotherapy regimens.²

According to data from 2 single-arm clinical trials evaluating nelarabine, rates of complete response (CR) and CR with incomplete hematologic or bone marrow recovery (CRi) were 13% and 23% in the pediatric population, respectively; the respective CR and CRi rates for the adult population were 18% and 21%.²

Nelarabine carries a boxed warning on its prescribing information for neurologic toxicity such as peripheral neuropathy,^3,4 which was found to be dose limiting in both age groups.² Other severe toxicities associated with nelarabine include hematologic, hepatic, and metabolic laboratory abnormalities in pediatric patients, and gastrointestinal and pulmonary toxicities in adult patients.^2,3

REFERENCES

1. Shorla Oncology® announces U.S. FDA approval of larger vial size for nelarabine intravenous administration for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. News release. Shorla Oncology. January 28, 2026. Accessed January 28, 2026. https://tinyurl.com/bdzzuydm

2. Cohen MH, Johnson JR, Justice R, Pazdur R. FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma. Oncologist. 2008;13(6):709-714. doi:10.1634/theoncologist.2006-0017

3. 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

4. Prescribing information – Arranon injection. Novartis. Updated July 2019. Accessed January 28, 2026. https://tinyurl.com/2hst3rn4