> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Immunomedics BLA for Sacituzumab Govitecan Accepted
- URL: https://www.fdaweb.com/immunomedics-bla-for-sacituzumab-govitecan-accepted/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141905

FDA has accepted for priority review an Immunomedics BLA for sacituzumab govitecan and its use in treating patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. Sacituzumab govitecan is described by the company as a novel, first-in-class antibody-drug conjugate. The filing is based on Phase 1/2 data, the company says. The user fee review action target date is 1/18/2019.