The U.S. Food and Drug Administration (FDA) has approved a new injectable treatment, Tepylute, designed to simplify and enhance the administration of thiotepa, a drug used in the treatment of breast and ovarian cancers. This approval introduces a ready-to-dilute formulation that aims to improve the preparation process and ensure dosing accuracy.

Tepylute, formerly known as SH-105, replaces the need for the complex reconstitution process associated with thiotepa’s traditional lyophilized powder form, thereby reducing potential preparation errors.

According to estimates from the American Cancer Society, in 2024, over 300,000 women will be diagnosed with breast cancer, and approximately 19,680 will be diagnosed with ovarian cancer in the United States. The introduction of Tepylute provides a new option for treating these prevalent cancers.