FDA Approves Tepylute for Breast and Ovarian Cancer Treatment

The FDA has approved a new drug application for Tepylute, a ready-to-dilute formulation to treat breast and ovarian cancers.

The FDA has approved a new drug application (NDA) for Tepylute (formerly SH-105), a ready-to-dilute formulation to treat adenocarcinoma of the breast and ovary.1,2

Tepylute is a liquid form of the standard-of-care agent, thiotepa. The new formulation of the agent eliminates the need for complex and time-consuming reconstitution and allows for consistent accuracy for dosing.

The recommended dose of the agent is 0.3 mg/kg to 0.4 mg/kg administered intravenously and at 1- to 4-week intervals. The higher dose in the range is usually administered initially and the maintenance dose should be adjusted weekly based on pretreatment control blood counts and subsequent blood counts, according to the FDA.

‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation," Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, stated in a press release.1 "We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a hazardous drug."

Another agent in the pipeline is SH-201, which is a liquid treatment that is administered orally for patients with select forms of leukemia, including chronic myeloid leukemia and acute lymphoblastic leukemia, and other cancers.3 In April 2024, Shora Oncology, the drug developer, reported that the FDA accepted for review an NDA seeking approval of the agent. They are slated to decide on the application by November 30, 2024, under the Prescription Drug User Fee Act.

References

  1. Shorla Oncology announces FDA approval for Tepylute, a novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. June 28, 2024. Accessed June 28, 2024. https://finance.yahoo.com/news/shorla-oncology-announces-fda-approval-110000280.html
  2. Tepylute. Prescribing information. Shorla Oncology; 2024. Accessed June 28, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216984s000lbl.pdf
  3. 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 June 28, 2024. https://shorlaoncology.com/shorla-oncology-announces-fda-filingacceptance-of-new-drug-application-to-treatcertain-forms-of-leukemia-and-other-cancers/