The Food and Drug Administration (FDA) granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body, the agency announced.
Patients must have received at least two prior therapies before taking Trodelvy.
The FDA’s accelerated approval process enables the agency to approve drugs for serious conditions to fill an unmet medical need. However, the agency requires clinical trials to verify the clinical benefit of the treatment.
Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that helps the cancer grow, divide and spread, and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells, according to the FDA.
Approximately two out of every 10 breast cancer diagnoses worldwide are triple-negative. Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2 (HER2) protein. Therefore, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2, the FDA said.
The FDA approved Trodelvy 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. Approximately 33 percent of those patients saw their tumors shrink. Of the patients with a response to Trodelvy, 55.6 percent maintained their response for 6 or more months and 16.7 percent maintained their response for 12 or more months.
