An overview of Perjeta and why it is authorised in the EU
Perjeta is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called HER2 is found on the cancer cells). Perjeta is used in the following situations:
- treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery. In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
- treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
- treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.
Perjeta contains the active substance pertuzumab.
Perjeta : EPAR - Medicine overview (PDF/84.02 KB)
First published: 02/04/2013
Last updated: 28/06/2018
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Roche Registration GmbH
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28/03/2019 Perjeta - EMEA/H/C/002547 - PSUSA/00010125/201806
- 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
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Metastatic Breast Cancer:
Perjeta is indicated for use in combination with trastuzumab and 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.
Neoadjuvant Treatment of Breast Cancer:
Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.