Priority Review for Immunomedics' ADC for TNBC

FDA accepted and granted Priority Review to a BLA from Immunomedics Inc. (NASDAQ:IMMU) seeking accelerated approval of sacituzumab govitecan (IMMU-132) to treat metastatic triple-negative breast cancer in a third-line setting. Its PDUFA date is Jan. 18, 2019.

Immunomedics said sacituzumab would be the first antibody-drug conjugate (ADC) approved to treat metastatic TNBC. It is a humanized antibody against epithelial glycoprotein-1 (EGP-1) conjugated with SN-38, the active metabolite of irinotecan. Sacituzumab has breakthrough therapy designation in the third-line indication...