On January 28, 2026 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the U.S. Food and Drug Administration has approved the company’s oncology drug, Nelarabine Injection, in a larger vial size, 375mg/75mL, for adult and pediatric patients with T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection carries a Boxed Warning. Please see Important Safety Information below and full Prescribing Information, including a Boxed Warning.

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This larger vial size is the second FDA approval of Nelarabine Injection from Shorla, both using the same formulation. The first approval, for a 250mg/50mL vial, was introduced to help address ongoing product shortages in the U.S. market. Depending on the dose, the new 375mg/75mL vial offers greater dosing flexibility for pediatric patients and provides higher-dosing options for adults. Its larger volume can allow for more precise dosing based on individual treatment needs.

"We are delighted to offer this new larger vial size of Nelarabine Injection to better serve adult and pediatric patients with T-cell leukemia and lymphoma," said Sharon Cunningham, CEO and Co-Founder of Shorla Oncology. "Both adult and pediatric patients have differing dose needs, which can make treatment preparation complex. With this FDA approval, we hope to support healthcare providers in delivering care more efficiently, reducing waste, and improving precision in managing these types of aggressive blood cancers."

T-cell acute lymphoblastic leukemia is an aggressive blood cancer in which too many T-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. T-ALL affects both pediatric and adult populations, yet treatment needs differ due to variation in body surface (BSA). The median age of diagnosis for pediatric T-ALL is nine years, with an average BSA of 1.07 m², which requires a 696 mg dose. The new 375mg vial’s flexibility could enable precise dosing with fewer vials. Additionally, adult patients have an average BSA of 1.7 m² and typically demand a higher nelarabine dose of approximately 2,550 mg.

"Launching Nelarabine Injection, as our first product in the U.S., was a major milestone. Expanding that footprint with a 375mg 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, CTO and Co-Founder of Shorla Oncology. "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."

(Press release, Shorla Oncology, JAN 28, 2026, View Source [SID1234662330])