Trodelvy
sacituzumab govitecan
Table of contents
Overview
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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Trodelvy : EPAR - Medicine overview (PDF/118.42 KB)
First published: 24/11/2021
Last updated: 11/08/2023
EMA/328204/2023 -
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Trodelvy : EPAR - Risk-management-plan summary (PDF/160.55 KB)
First published: 24/11/2021
Last updated: 11/08/2023
Authorisation details
Product details | |
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Name |
Trodelvy
|
Agency product number |
EMEA/H/C/005182
|
Active substance |
Sacituzumab govitecan
|
International non-proprietary name (INN) or common name |
sacituzumab govitecan
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01FX06
|
Additional 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 | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
22/11/2021
|
Contact address |
Carrigtohill |
Product information
26/07/2023 Trodelvy - EMEA/H/C/005182 - II/0020
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.