Phesgo

RSS

pertuzumab / trastuzumab

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

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.

This EPAR was last updated on 13/01/2021

Authorisation details

Product details
Name
Phesgo
Agency product number
EMEA/H/C/005386
Active substance
  • pertuzumab
  • trastuzumab
International non-proprietary name (INN) or common name
  • pertuzumab
  • trastuzumab
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XY
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
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
21/12/2020
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

21/12/2020 Phesgo - EMEA/H/C/005386 -

Contents

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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.

Assessment history

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