FDA Accepts Shorla Oncology's NDA for Oral Liquid SH-201 in Leukemia and Other Cancers
Key Insights
The FDA has accepted Shorla Oncology (search)'s New Drug Application (NDA) for SH-201, an oral liquid formulation designed to treat specific types of leukemia (search) and other cancers.
SH-201 aims to provide an alternative treatment option for patients who lack access to an oral liquid formulation, addressing a significant unmet need in cancer therapy.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2024, for SH-201, indicating the timeline for the agency's decision.
Shorla Oncology (search), a U.S.-Ireland specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SH-201, a palatable oral liquid formulation of a chemotherapeutic agent. This drug is intended for the treatment of certain forms of leukemia (search) and other cancers, offering a new option for patients who may not have access to existing oral liquid treatments. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2024.
Addressing Unmet Needs in Leukemia Treatment
SH-201 is designed to slow or stop the growth of certain cancers, including Chronic Myeloid Leukemia (search) (CML) and Acute Lymphoblastic Leukemia (search) (ALL). According to the American Cancer Society, approximately 9,280 new patients are diagnosed with CML and 6,550 with ALL each year in the U.S. The availability of a palatable oral liquid formulation addresses a key unmet need, particularly for patients who have difficulty swallowing pills or prefer liquid medication.
Shorla Oncology's Growing Portfolio
This NDA acceptance marks Shorla Oncology (search)'s second in 2024, following the acceptance of SH-105, a ready-to-dilute formulation for adenocarcinoma of the breast or ovary. Shorla Oncology also markets Nelarabine for T-cell Leukemia (search) and JYLAMVO, an oral methotrexate solution for acute lymphoblastic leukemia (search) and other indications. The company recently secured $35 million in Series B funding to accelerate the growth of its oncology portfolio.
About SH-201
SH-201 is the first palatable oral liquid of its kind in the U.S. It is designed to provide a more convenient and accessible treatment option for patients with certain forms of leukemia (search) and other cancers.
Shorla Oncology's Focus
Founded in 2018, Shorla Oncology (search) focuses on developing innovative oncology drugs for orphan and pediatric cancers. The company targets indications where existing treatments are limited, in shortage, or inadequate for the target population. Shorla's mission is to bring accessible, affordable, and life-saving treatments to patients, contributing to improved patient care.