FDA Considers SH-201 for Treating Certain Leukemias and Cancers


SH-201 is a new, promising option for certain types of leukemias, including chronic myeloid leukemia and acute lymphoblastic leukemia, as well as other cancers.

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  • The new drug application (NDA) for SH-201 has been accepted for priority review by the FDA.
  • A Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2024, has been set.
  • This marks the second FDA acceptance for an NDA filing by the company, Shorla Oncology, in 2024, as SH-105 was accepted in January.

The FDA has accepted the NDA of SH-201 for review as a potential treatment for certain forms of leukemia and other cancers.1

SH-201 is the first palatable oral liquid of the related chemotherapeutic agent to treat various types of cancers. The agent works to slow or prevent the growth of certain forms of leukemia and other cancers, including chronic myeloid leukemia and acute lymphoblastic leukemia (ALL), myelodysplastic syndrome, and gastrointestinal tumors.2

A PDUFA action date has been set for November 30, 2024.1

“With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of US 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 cofounder of Shorla Oncology, in a 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.”

3D rendering of red blood cells: © Kodjovi - stock.adobe.com

3D rendering of red blood cells: © Kodjovi - stock.adobe.com

The acceptance to file the NDA of SH-201 follows the acceptance to file for SH-105 in January of this year. SH-105 is a novel, differentiated ready-to-dilute formulation for the treatment of adenocarcinoma of the breast or ovary that has a PDUFA target action date set for June 24, 2024.

Another agent in the Shorla Oncology pipeline is SH-110, an oral treatment for glioma. The company has already had a pre investigational NDA meeting with the FDA for SH-110.

Additionally, Shorla Oncology manufactures Jylamvo, the only approved, oral methotrexate solution for adults, and nelarabine, an injection for the treatment of T-cell ALL and T-cell lymphoblastic lymphoma.2

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://tinyurl.com/dbrczpjw
2. Pipeline. Shorla Oncology. Accessed April 8, 2024. https://shorlaoncology.com/pipeline/sh-201/
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