FDA Accepts NDA for SH-201 in Leukemia and Other Cancers

The FDA has accepted the new drug application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent, for the treatment of certain forms of leukemia and other cancers, according to a press release from Shorla Oncology.¹

The regulatory body assigned a Prescription Drug User Fee Act action date of November 30, 2024.

“With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of United States patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, stated in the press release. “Submitting this drug to the FDA for review is more than just a milestone for our company, it’s an important moment for all those impacted by this disease including patients, caregivers and clinicians.”

SH-201 is an oral liquid therapy designed to impede the progression of specific types of leukemia and other malignancies, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), which affects approximately 9,280 and 6,550 new patients, respectively, each year in the United States.

“The FDA’s action today ensures that Shorla [Oncology] is well positioned to bring this innovative oral drug to market,” Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, added in the press release. “SH-201 addresses key areas of unmet need by providing a palatable liquid treatment option for patients suffering with cancer.”

Earlier in January 2024 the FDA accepted an NDA for SH-105, a novel ready-to-dilute formulation targeting adenocarcinoma of the breast or ovary.^1,2 SH-105 is a novel formulation of a long-standing medication traditionally administered in freeze-dried powder form since the 1950s. Presented in a ready-to-dilute liquid form, SH-105 eliminates the necessity for powder reconstitution, a feature Shorla Oncology says will enhance operational efficiency and mitigate the potential risks linked with drug preparation.²

In addition, the company is focusing on marketing two of their products, which received designations from the FDA in 2022 and 2023. Specifically in March 2023, the FDA approved treatment with nelarabine (SH-111) for injection for patients with T-cell ALL and T-cell lymphoblastic lymphoma. In November 2022, Jylamvo received approval, becoming the sole oral methotrexate solution approved in the United States for adult use in ALL and other indications.^1-4

References

1. Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukemia and other cancers. News release. Shorla Oncology. April 8, 2024. Accessed April 8, 2024. https://shorlaoncology.com/shorla-oncology-announces-fda-filingacceptance-of-new-drug-application-to-treatcertain-forms-of-leukemia-and-other-cancers/
2. Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. January 9, 2024. Accessed April 8, 2024. https://shorlaoncology.com/shorla-oncology-announces-fda-filing-acceptance-of-new-drug-application-for-novel-formulation-to-treat-breast-and-ovarian-cancer/
3. Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. News release. Shorla Oncology. March 9, 2023. Accessed April 8, 2024. https://shorlaoncology.com/shorla-oncology-announces-u-s-fda-approval-of-nelarabine-injection-for-the-treatment-of-t-cell-leukemia/
4. Shorla Oncology & EVERSANA announce U.S. commercial launch of FDA-approved JYLAMVO, the first and only oral methotrexate solution approved in the U.S. for adults. News release. Shorla Oncology. December 19, 2023. Accessed January 10, 2024. https://www.biospace.com/article/releases/shorla-oncology-and-amp-eversana-announce-u-s-commercial-launch-of-fda-approved-jylamvo-the-first-and-only-oral-methotrexate-solution-approved-in-the-u-s-for-adults/