Date: 31-Dec-2019

US FDA accepts Immunomedics' BLA resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer

Immunomedics, a leading biopharmaceutical company in the area of antibody-drug conjugates, announced that the US Food and Drug Administration (FDA) has accepted for filing the company's Biologics License Application (BLA) 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, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020. We are pleased that the FDA has accepted our resubmission, which was a top priority for us in 2019, said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. We look forward to working closely with the FDA to facilitate their review of our BLA to enable us to bring this potentially transformational treatment to patients affected by mTNBC. Sacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the FDA. TNBC is an aggressive disease with an annual incidence estimated to be about 40,000 people, approximately 15% of all breast cancer types, in the United States alone. The incidence rate is higher among younger women and highest among non-Hispanic black and Hispanic women. TNBC tumors do not have sufficient estrogen, progesterone or HER2 receptor expression to indicate the use of hormonal or HER2-directed therapy. There is currently no standard-of-care chemotherapy for people with relapsed/refractory mTNBC. An overall response rate of about 10% and median progression-free survival of 2-3 months have recently been reported in late-stage mTNBC using single-agent chemotherapy.