FDA Accepts BLA, Grants Priority Review for Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a biologics license application (BLA) 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. The prescription drug user fee act target action date is January 18, 2019.
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 of sacituzumab govitecan in metastatic triple-negative breast cancer.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
