FDA Approves Nelarabine Injection for T-cell Leukemia and Lymphoma

The FDA has approved nelarabine for injection (SH-111) for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), providing patients with an alternative to a treatment that has historically been in shortage, according to an announcement from Shorla Oncology.¹

In August 2017, the company announced a partnership with the commercial services company Eversana to support the launch and commercialization of Shorla’s oncology pipeline,² which is now focused on the launch of nelarabine injection.

“We are very proud to see our research in oncology innovation and dedication to patient care culminate in this U.S. FDA approval,” Sharon Cunningham, chief executive officer and cofounder of Shorla Oncology, said in a press release. “Nelarabine injection is a critical treatment for patients living with T-cell Leukemia, particularly for children with leukemia, and it is our hope that [this] approval addresses the clinical need in this patient community.”

T-cell leukemia is an aggressive and highly proliferative hematologic cancer diagnosed most often in children.

“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,” added Orlaith Ryan, chief technology officer and cofounder of Shorla Oncology.

In 2005, the FDA approved nelarabine (Arranon), manufactured by GlaxoSmithKline.³ The approval was indicated for the treatment of patients with T-ALL and T-LBL whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. The agent was approved for intravenous use at a dose of 1,500 mg/m² delivered over 2 hours on days 1, 3, and 5 every 21 days for adults and 650 mg/m² over 1 hour daily for 5 consecutive days every 21 days for children. Approval was based solely on the rate of complete response, and randomized trials had not been conducted to demonstrate survival or other clinical benefits.

In April 2021, the FDA accepted Shorla’s application for nelarabine injection for filing for the treatment of patients with T-cell leukemia.⁴

“Successful treatment of children, adolescents, and young adults with cancer, such as children with T-ALL, is dependent on stable access to critical chemotherapy agents. Drug shortages directly impact patient outcome,” 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, 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.”

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

References

1. Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. News release. Shorla Oncology. March 7, 2023. Accessed March 13, 2023. https://www.businesswire.com/news/home/
2. Shorla Pharma announces partnership with Eversana to support the launch and commercialization of T-cell leukemia treatment. News release. Shorla Pharma. August 17, 2021. Accessed March 13, 2023. https://www.eversana.com/2021/08/17/
3. Arranon Prescribing Information. FDA. Accessed March 13, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/
4. Shorla Pharma announces FDA filing acceptance and priority review for T-cell leukemia treatment. News release. Shorla Pharma Limited. April 23, 2021. Accessed March 13, 2023. https://www.businesswire.com/news/home/