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# Shorla Oncology Breast/Ovarian Cancer Drug OK’d
- URL: https://www.fdaweb.com/shorla-oncology-breast-ovarian-cancer-drug-okd/
- Published: 2024-06-28T12:00:00.000Z
- Updated: 2026-09-14T14:34:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157276

FDA has approved a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer. “This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” the company says. “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.”

Tepylute is described as a liquid form of standard-of-care oncology drug thiotepa. The new formulation eliminates the need for complex and time-consuming reconstitution, which leads to additional risks of drug preparation errors, the company says.