Orlaith Ryan and Sharon Cunningham. Image: Shorla
The Clonmel-headquartered start-up specialises in developing innovative oncology drugs, with a focus on orphan and paediatric cancers.
The US Food and Drug Administration (FDA) has approved Shorla Pharma’s oncology drug for the treatment of leukaemia.
The company, which trades as Shorla Oncology, was established in 2018 by Sharon Cunningham and Orlaith Ryan.
The newly approved drug, Nelarabine Injection, is designed to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).
T-cell leukaemia is an aggressive blood and bone marrow cancer which progresses quickly and is more common in children.
The Clonmel-headquartered start-up specialises in developing innovative oncology drugs, with a focus on orphan and paediatric cancers.
It first sought FDA approval for its leukaemia drug almost two years ago. This is Shorla’s first product approved for the US market.
Shorla’s CEO and co-founder, Sharon Cunningham, said she is very proud to see the company’s research in oncology innovation culminate in FDA approval.
“Nelarabine Injection is a critical treatment for patients living with T-cell leukaemia, particularly for children with leukaemia, and it is our hope that today’s approval addresses the clinical need in this patient community.”
Dr Stephen P Hunger is chief of the division of oncology and director of the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia. He said successful treatment of children, adolescents and young adults with cancer is dependent on stable access to critical chemotherapy agents.
“Drug shortages directly impact patient outcome,” he said. “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.”
Orlaith Ryan, CTO and co-founder, said Shorla hopes to bring the new drug 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.”
Shorla raised $8.3m in Series A funding in 2020, in a round led by Seroba Life Sciences.
It said at the time that this capital would be used to advance its product pipeline and expand its technical and commercial operations in Ireland and the US.
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