Sacituzumab govitecan was initially approved in April 2020 under accelerated 
approval for the treatment of patients with metastatic triple-negative breast 
cancer who received at least two prior therapies for metastatic disease. A 
confirmatory phase III trial evaluating sacituzumab govitecan vs. chemotherapy 
of the provider's choice was published in April 2021. Based on this trial, the 
FDA granted sacituzumab govitecan full regulatory approval. This antibody-drug 
conjugate is composed of a monoclonal antibody targeted at Trop-2 and contains 
the active metabolite of irinotecan, SN-38, as a cytotoxic side moiety. In a 
phase III clinical trial, sacituzumab govitecan demonstrated a median 
progression-free survival of 5.7 months vs. 1.7 months with chemotherapy. It is 
now an additional option for patients with metastatic triple-negative breast 
cancer who received at least two prior therapies for metastatic disease.