FDA Grants Priority Review for Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
Posted: Wednesday, August 1, 2018
The U.S. Food and Drug Administration (FDA) recently accepted a biologics license application for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first antibody-drug conjugate approved for the treatment of metastatic triple-negative breast cancer. The filing is based on data from a phase I/II trial that investigated sacituzumab govitecan in metastatic triple-negative breast cancer.