FDA Approves Shorla’s Treatment for Certain T-Cell Cancers

Rare Daily Staff

The U.S. Food and Drug Administration approved Shorla Oncology’s nelarabine injection for the treatment of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma.

It is the company’s first approved product.

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. The company said nelarabine injection provides patients with an alternative to a product that has historically been 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,” said Stephen Hunger, chief of the division of Oncology and director of the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia. “Drug shortages directly impact patient outcome.”

In preparation for the immediate commercial launch of nelarabine injection, Shorla is working with its commercialization services partner, Eversana. The two companies announced in August 2021 entered into an agreement on nelarabine injection that allows Shorla to maintain ownership as well as all financial, legal, regulatory, and manufacturing responsibilities for the product. Eversana received the exclusive right to support all commercialization activities for the drug.

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

Photo: Sharon Cunningham, CEO and co-founder of Shorla Oncology