Home / FDA News / Immunomedics Resubmits its BLA to the FDA for Accelerated Approval of Sacituzumab Govitecan for Treatment of Metastatic Triple-Negative Breast Cancer

Immunomedics Resubmits its BLA to the FDA for Accelerated Approval of Sacituzumab Govitecan for Treatment of Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) — Immunomedics, 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.”

About Immunomedics

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.

Check Also

ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. …