sacituzumab govitecan

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 11/08/2023

Authorisation details

Product details
Agency product number
Active substance
Sacituzumab govitecan
International non-proprietary name (INN) or common name
sacituzumab govitecan
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Date of issue of marketing authorisation valid throughout the European Union
Contact address

County Cork T45 DP77

Product information

26/07/2023 Trodelvy - EMEA/H/C/005182 - II/0020

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

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