Posted by Michael Wonder on 21 May 2018
Immunomedics submits biologics license application for sacituzumab govitecan to the U.S. Food and Drug Administration
21 May 2018 - First-in-class antibody-drug conjugate had received prior breakthrough therapy designation from the FDA for the treatment of metastatic triple-negative breast cancer.
Immunomedics today announced the submission of a biologics license application to the U.S. FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only antibody-drug conjugate approved for the treatment of mTNBC.
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
