Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Breast Neoplasms;Triple Negative Breast Neoplasms, Date of authorisation: 22/11/2021, Revision: 3, Status: Authorised
Trodelvy is a cancer medicine used to treat adults with a type of breast cancer known as triple-negative breast cancer. In triple-negative breast cancer, the cancer cells do not have receptors (targets) for certain hormones on their surface and do not make abnormally high levels of a protein called HER2 (HER2-negative). In these patients, the medicine is used when it is not possible to remove the cancer with surgery because the cancer has spread to areas outside the breast (locally advanced) or to other parts of the body (metastatic). It is used in patients who have had two or more prior systemic (whole body) treatments, including at least one of them for advanced disease.
Trodelvy is also used for treating breast cancer when the cancer cells have receptors for certain hormones on their surface (HR-positive) and are HER2-negative. It is used in patients who have had endocrine-based therapy (hormone treatment) as well as two or more prior systemic treatments when their cancer cannot be removed by surgery or is metastatic.
Trodelvy contains the active substance sacituzumab govitecan.
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