FDA Grants Priority Review and accepts BLA for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer

FDA Grants Priority Review and accepts BLA for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer

Source: 
CP Wire
snippet: 
  • PDUFA target date is 1/18/19
  • Sacituzumab govitecan is an antibody drug conjugate (ADC)
  • If appproved it would be the first ADC approved for mTNBC
  • Company has another ADC in Ph II for metastatic colorectal cancer