FDA Accepts Shorla Oncology's NDA for Oral Liquid Leukemia Drug SH-201

• The FDA has accepted Shorla Oncology's New Drug Application (NDA) for SH-201, an oral liquid formulation of a chemotherapy drug used to treat certain forms of leukemia.
• The FDA's decision on the approval of SH-201 is expected by November 30, 2024, under the Prescription Drug User Fee Act (PDUFA).
• SH-201 offers an alternative treatment option for leukemia patients who have difficulty swallowing tablets or other solid dosage forms, addressing an unmet need.
• Shorla Oncology acquired the rights to SH-201 in July 2023 and is preparing for the launch, commercialization, and sales of the drug in the U.S.

Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SH-201, an oral liquid formulation of a chemotherapeutic agent used in the treatment of certain leukemias. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2024.

SH-201 is designed as a palatable oral liquid, intended to slow or stop the growth of certain forms of leukemia and other cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). This formulation aims to provide an accessible treatment option for patients who may struggle with traditional solid dosage forms.

Addressing Unmet Needs in Leukemia Treatment

According to the American Cancer Society, approximately 9,280 new cases of CML and 6,550 new cases of ALL are diagnosed each year in the U.S. SH-201 is poised to address key areas of unmet need by providing a palatable liquid treatment option for patients suffering from these cancers.

"With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of U.S. patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid," said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology.

Shorla Oncology's Expanding Portfolio

Shorla Oncology obtained the rights to SH-201 in July 2023. The company is now responsible for the launch, commercialization, and sales of SH-201 in the US. This NDA acceptance follows the FDA's acceptance to file in January 2024 for SH-105, a novel, ready-to-dilute formulation for the treatment of adenocarcinoma of the breast or ovary.

In March 2023, the FDA approved Shorla’s Nelarabine injection (SH-111) for T-cell leukemia. Shorla also acquired Jylamvo (methotrexate) from Therakind for commercialization in the US, which is approved to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis.

Financial Backing and Future Prospects

In October 2023, Shorla secured $35 million in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, to bolster its oncology portfolio growth and advance drug candidates like SH-201.