Immunomedics Resubmits Biologics License Application to the FDA for Sacituzumab Govitecan
- Category: Antibodies
- Published on Wednesday, 04 December 2019 10:55
- Hits: 1066
MORRIS PLAINS, NJ, USA I December 03, 2019 IImmunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
“We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the Agency during the BLA review,” said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC.”
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.