Herceptin

RSS

trastuzumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Herceptin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Herceptin.

This EPAR was last updated on 06/09/2018

Authorisation details

Product details
Name
Herceptin
Agency product number
EMEA/H/C/000278
Active substance
trastuzumab
International non-proprietary name (INN) or common name
trastuzumab
Therapeutic area (MeSH)
  • Stomach Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC03
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
27/08/2000
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

23/08/2018 Herceptin - EMEA/H/C/000278 - IB/0144

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

Breast cancer

Metastatic breast cancer

Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer:

  • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments;
  • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable;
  • in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease;
  • in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab.

Early breast cancer

Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer:

  • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable);
  • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel;
  • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin;
  • in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.

Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer

Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease.

Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating