Trodelvy

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sacituzumab govitecan

Authorised
This medicine is authorised for use in the European Union.

Overview

Trodelvy is a cancer medicine used to treat adults with a type of breast cancer known as triple-negative breast cancer. It 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 contains the active substance sacituzumab govitecan.

This EPAR was last updated on 17/01/2022

Authorisation details

Product details
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)
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC
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
22/11/2021
Contact address

Carrigtohill
County Cork T45 DP77
Ireland

Product information

22/11/2021 Trodelvy - EMEA/H/C/005182 -

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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