Pharma Focus Europe

Shorla Oncology Receives FDA Acceptance for New Drug Application Targeting Specific Forms of Leukemia and Other Cancers

Wednesday, April 10, 2024

Shorla Oncology, a specialty pharmaceutical company headquartered in both the United States and Ireland, has made a significant announcement today. The U.S. Food and Drug Administration (FDA) has officially accepted Shorla's New Drug Application (NDA) for SH-201, marking an important step forward in the search for effective treatments for leukemia and other cancers. This drug, presented as the first palatable oral liquid of its kind, holds promise for patients battling certain forms of leukemia and related cancers.

Sharon Cunningham, the Chief Executive Officer and Co-Founder of Shorla Oncology, expressed optimism about this milestone, highlighting its potential to provide a much-needed alternative for numerous U.S. patients confronting leukemia and other cancer types. She emphasized the significance of this achievement not only for the company but also for the broader community impacted by these diseases, including patients, caregivers, and medical professionals.

SH-201, the oral liquid treatment, has shown efficacy in slowing or halting the progression of specific types of leukemia and other cancers, including Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia. The FDA's acceptance of the NDA reflects a significant stride towards making this innovative treatment option available to those in need.

Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology, echoed the sentiment, emphasizing SH-201's ability to address critical areas of unmet need by presenting a palatable liquid option for cancer patients. The acceptance of the NDA by the FDA is a testament to the company's dedication to bringing impactful solutions to the market.

This latest development with SH-201 follows the earlier announcement in January regarding the acceptance to file SH-105, a distinct ready-to-dilute formulation designed for treating adenocarcinoma of the breast or ovary. SH-105 is currently undergoing FDA review, demonstrating the company's ongoing commitment to expanding its oncology portfolio. Bolstered by a recent $35 million Series B funding round, Shorla Oncology has been able to accelerate its efforts in this regard. Notably, the company has previously introduced Nelarabine for T-cell Leukemia treatment and JYLAMVO, the first oral methotrexate solution approved in the U.S. for adult use in treating acute lymphoblastic leukemia and other conditions.

In summary, SH-201 represents a groundbreaking advancement in cancer treatment, offering hope to patients and signaling a significant step forward in the fight against leukemia and related cancers.



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