US FDA Approves Shorla Oncology’s Nelarabine Injection to Treat T-Cell Leukemia


Nelarabine Injection, an oncology drug developed by Shorla Oncology, has received US FDA approval for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection offers patients a substitute for a product that has historically been scarce.

Sharon Cunningham, CEO and co-founder of Shorla Oncology, said that they are very proud to see their research in oncology innovation and dedication to patient care culminate in this US FDA approval. Nelarabine injection is an essential treatment for T-cell leukemia patients, particularly children, and they hope that this approval addresses the clinical need in this patient community.

They are honored to bring this much needed product to patients in the United States and hopefully to patients worldwide in the near future, said Orlaith Ryan, CTO and co-founder of Shorla Oncology. This milestone reaffirms our commitment to developing cutting-edge oncology treatments, focusing on rare cancers for which there are limited, unavailable, or inadequate options.

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T-cell leukemia is a blood and bone marrow cancer that grows quickly and is aggressive. While the majority of leukemias affect older people, T-cell leukemia is more prevalent in children and receives fewer treatment options than other types.

According to 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, stable access to essential chemotherapy agents is essential for the successful treatment of children, adolescents, and young adults with cancer, like T-cell acute lymphoblastic leukemia. The approval of Nelarabine Injection and the significant impact they anticipate it will have on treatment accessibility and patient care are encouraging to them.

Shorla Oncology focuses on developing cutting-edge treatments for pediatric and orphan cancers. The company has an advanced pipeline of oncology therapies to treat a number of unmet patients’ needs with strong support from scientists and clinicians.