Posted by Michael Wonder on 26 Dec 2019
Immunomedics announces FDA acceptance for filing of biologics license application resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer
26 December 2019 - Prescription Drug User Fee Act target action date set for 2 June 2020.
Immunomedics today announced that the U.S. FDA has accepted for filing the Company’s biologics license application seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease, as a complete class 2 response.
The PDUFA target action date of the resubmitted application is 2 June 2020.
Sacituzumab govitecan has been awarded both fast track designation and breakthrough therapy designation by the FDA.
