The Biologics License Application (BLA) for sacituzumab govitecan (Immunomedics), a treatment for patients with metastatic triple-negative breast cancer (mTNBC), has been accepted for filing and granted Priority Review by the Food and Drug Administration (FDA).

Sacituzumab govitecan is a novel, first-in-class antibody-drug conjugate specifically being evaluated in mTNBC patients who previously received ≥2 prior therapies for metastatic disease. The BLA is based on data from a Phase 1/2 trial of sacituzumab govitecan. The treatment is currently being investigated in the Phase 3 ASCENT study in which patients with mTNBC refractory or relapsing after ≥2 prior chemotherapies (including a taxane) are being randomized to receive either sacituzumab govitecan or treatment of physician choice; the primary outcome measure will be progression free survival, with overall survival, objective response rate, duration of response, and time to onset of response as secondary outcomes. 

Related Articles

The FDA has set a Prescription Drug User Fee Act date of January 18, 2019, for the treatment. “We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously,” said Michael Pehl, president and CEO of Immunomedics.

For more information visit