Basic Information
Trodelvy
Regulatory Information
EMEA/H/C/005182
November 22, 2021
September 16, 2021
4
June 5, 2024
Company Information
Ireland
Carrigtohill County Cork T45 DP77
GILEAD SCIENCES IRELAND UC
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.
Overview Summary
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.