Shorla Oncology Scores Major Breakthrough with FDA Approval of Revolutionary Leukemia Treatment Nelarabine Injection

Shorla Oncology, a US-Ireland pharmaceutical company, is proud to announce that its oncology drug, Nelarabine Injection, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). This marks the first product that Shorla has brought to the US market, offering an alternative to a product that has historically been in shortage. It is a major milestone for Shorla and a significant step forward for cancer patients.

Shorla Oncology is thrilled to announce the U.S. FDA approval of Nelarabine Injection, a critical treatment for patients who are living with T-cell Leukemia. This innovative oncology research and dedication to patient care is a major accomplishment, especially for children with leukemia who will now have access to this potentially life-saving therapy. We are proud to have reached this milestone and are hopeful that today’s approval will help provide relief to those in need.

We are thrilled to announce that Shorla Oncology’s revolutionary new product is now available in the United States and soon in countries around the world! Our CTO and Co-founder, Orlaith Ryan, expresses her excitement and gratitude for this milestone, as it furthers our dedication to developing treatments for rare cancers where existing treatments are inadequate, scarce, or non-existent. Together, we can make a lasting difference in the lives of countless patients by providing innovative, life-saving oncology solutions.

T-cell leukemia is a rapidly progressing blood and bone marrow cancer that predominantly affects children, making it a particularly concerning form of leukemia. Unfortunately, treatments are often in short supply, making this a particularly challenging form of cancer to fight. Despite the fact that leukemias usually target older people, T-cell leukemia is most common among kids, making it a particularly heartbreaking diagnosis.

The Children’s Hospital of Philadelphia’s Division of Oncology and Center for Childhood Cancer Research are thrilled by the recent approval of Nelarabine Injection, which will have a substantial impact on patient care and treatment access. Stephen P. Hunger, MD, Chief of the Division of Oncology and Director of the Center for Childhood Cancer Research, notes that treatment of young cancer patients, such as those with T-cell acute lymphoblastic leukemia, relies on the availability of critical chemotherapy agents; drug shortages can detrimentally affect patient outcomes. Nelarabine Injection is a major breakthrough that will help ensure children, adolescents and young adults have the necessary access to life-saving medication.

Shorla is revolutionizing the way we treat cancer. By focusing on orphan and pediatric cancers, the company has created an advanced pipeline of oncology therapies to tackle some of the most challenging unmet patient needs. With the support of leading scientists and clinicians, Shorla is committed to developing innovative solutions to fight cancer and improve patient outcomes.

We are thrilled to announce that Shorla Oncology has officially received its first U.S. FDA approval! This is an incredible milestone for the company, and it paves the way for the approval and commercialization of their exciting portfolio of oncology drugs. We can’t wait to see what the future holds for Shorla and look forward to a successful launch in the U.S. market.

In anticipation of the imminent launch of Nelarabine Injection, Shorla has partnered with EVERSANA® to provide comprehensive commercialization services. With this strategic collaboration, which was announced in August 2021, Shorla is poised to bring this revolutionary treatment to the market.

About Shorla Oncology

Shorla Oncology, founded by Sharon Cunningham and Orlaith Ryan in 2018, is a revolutionary pharmaceutical company with a mission to provide life-saving treatments for women’s, orphan and pediatric cancers. Through their advanced pipeline of innovative oncology drugs, they are focused on treating patients with limited, scarce or inadequate existing treatments, ensuring that they receive accessible, affordable and life-saving care. Shorla’s groundbreaking portfolio is making an incredible impact on the lives of those in need.

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