Shorla Oncology Announces U.S. FDA Approval of Nelarabine Injection for the Treatment of T-cell Leukemia

Nelarabine Injection ensures access to a lifesaving treatment that historically has been in shortage

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage. This marks the first product approved in the US market for Shorla.

“We are very proud to see our research in oncology innovation and dedication to patient care culminate in this U.S. FDA approval,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. “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.”

Added Orlaith Ryan, CTO and Co-founder of Shorla Oncology, “We are honored to bring this much needed product to patients in the U.S. and hopefully to patients worldwide in the near future. This milestone further fuels our passion and commitment to develop innovative oncology treatments, with a focus on rare cancers where existing treatments are limited, in short supply or inadequate.”

T-cell leukemia is an aggressive blood and bone marrow cancer which progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children, with this particular treatment often in shortage.

“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. “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.”

Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

“We are delighted to announce this first U.S. FDA approval for Shorla Oncology, and we look forward to a successful launch in the U.S.,” said Dennis Purcell, Chairman of the Board at Shorla. “This is an important milestone, as it paves the way for the approval and commercialization of the company’s promising portfolio of oncology drugs.”

In preparation for the immediate commercial launch of Nelarabine Injection, Shorla is working with its commercialization services partner, EVERSANA®, which it announced August 2021.

About Shorla Oncology

Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately held, Ireland- and US-based pharmaceutical company with an advanced pipeline of innovative oncology drugs for women's, orphan and pediatric cancers. The company concentrates on indications where existing treatments are limited, in shortage or inadequate for the target population. Shorla's growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care.

For further information, please visit www.shorlaoncology.com

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