Policy & Regulation
US FDA accepts Immunomedics' biologics license application for sacituzumab govitecan
20 July 2018 -

The US Food and Drug Administration (FDA) has accepted United States-based Immunomedics' biologics license application for filing and granted priority review for sacituzumab govitecan, it was reported yesterday.

The product is intended for the treatment of patients with metastatic triple-negative breast cancer who earlier received at least two prior therapies for metastatic disease. It is a novel, first-in-class antibody-drug conjugate (ADC).

The PDUFA deadline target action date is 18 January, 2019. If approved, the product would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer. The filing is based on Phase 1/2 data of sacituzumab govitecan in metastatic triple-negative breast cancer.