CAMBRIDGE, Mass. — Shorla Oncology said the U.S. Food and Drug Administration has approved a larger vial size of its oncology drug Nelarabine Injection for intravenous administration in adult and pediatric patients with T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma.
The newly approved 375 mg/75 mL vial is intended to address a critical dosing gap for patients with these aggressive blood cancers. Nelarabine Injection carries a Boxed Warning, and full prescribing information includes important safety information.
This marks the second FDA approval for Shorla’s Nelarabine Injection using the same formulation. The company previously received approval for a 250 mg/50 mL vial, which was introduced to help address ongoing product shortages in the U.S. market. Depending on the prescribed dose, the larger vial provides greater dosing flexibility for pediatric patients and higher-dose options for adults, while allowing for more precise dosing and potentially reducing drug waste.
“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 a fast-growing cancer in which excess immature T-cell lymphoblasts are found in the bone marrow and blood. The disease affects both children and adults, but dosing requirements vary based on body surface area. Pediatric patients have a median age of diagnosis of nine years and an average body surface area of 1.07 square meters, typically requiring a 696 mg dose. The larger 375 mg vial may allow for more accurate dosing with fewer vials. Adult patients, with an average body surface area of 1.7 square meters, often require higher doses 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 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, 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.”
