Immunomedic’s Trodelvy (sacituzumab govitecan-hziy) earned accelerated approval for treatment of adults with triple-negative breast cancer that has metastasized.
The approval was based on the results of a clinical trial of 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. The overall response rate was 33.3 percent, with a median duration of response of 7.7 months.
As a condition of the accelerated approval, the FDA said further trials will need to be conducted to evaluate its benefit. The agency previously granted the drug priority review, breakthrough therapy and fast-track designations.