Phesgo
pertuzumab / trastuzumab
Table of contents
Overview
Phesgo is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called HER2 is found on the cancer cells).
It is used in combination with other cancer medicines in:
- patients with early breast cancer (when the cancer has not spread to other parts of the body) at high risk of coming back, after they have surgery;
- patients with locally advanced, inflammatory breast cancer or with early breast cancer at high risk of coming back, before they have surgery;
- patients whose cancer that has come back locally after treatment and cannot be removed by surgery;
- patients with metastatic breast cancer (cancer that has spread to other parts of the body).
Phesgo contains the active substances pertuzumab and trastuzumab. For more information about the use of Phesgo and the other medicines the patients will receive, see the package leaflet.
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List item
Phesgo : EPAR - Medicine overview (PDF/151.14 KB) (new)
First published: 13/01/2021
EMA/620936/2020 -
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Phesgo : EPAR - Risk-management-plan summary (PDF/339.78 KB) (new)
First published: 13/01/2021
EMA/CHMP/646782/2020
Authorisation details
Product details | |
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Name |
Phesgo
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Agency product number |
EMEA/H/C/005386
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Breast Neoplasms
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Anatomical therapeutic chemical (ATC) code |
L01XY
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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 |
Roche Registration GmbH
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Date of issue of marketing authorisation valid throughout the European Union |
21/12/2020
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Contact address |
Product information
21/12/2020 Phesgo - EMEA/H/C/005386 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Early breast cancer (EBC)
Phesgo is indicated for use in combination with chemotherapy in:
- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
Metastatic breast cancer (MBC)
Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.