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.
Herceptin : EPAR - Summary for the public (PDF/94.57 KB)
First published: 04/11/2008
Last updated: 25/10/2013
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Roche Registration GmbH
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24/03/2021 Herceptin - EMEA/H/C/000278 - IB/0169
- 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
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.
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