Posted by Michael Wonder on 19 Jul 2018
FDA accepts biologics license application for filing and grants priority review for sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer
18 July 2018 - The Prescription Drug User Fee Act target action date is 18 January 2019.
Immunomedics today announced that the U.S. FDA has accepted the company’s biologics license application for filing and granted Priority Review 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 ADC approved for the treatment of mTNBC.
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
