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

MEEFRO March 8, 2023

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Nelarabine Injection ensures access to a lifesaving treatment, particularly for children, that historically has been in shortage.

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, announced that the 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). In preparation for the immediate commercial launch of Nelarabine Injection, Shorla is working with its commercialization services partner, EVERSANA®, which it announced August 2021.

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.

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.

Sharon Cunningham, CEO and Co-founder of Shorla Oncology, said: “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.”