EU approval and labelling information
Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Early breast cancer (EBC)
Herceptin is indicated for the treatment of patients with HER2-positive EBC following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
Metastatic breast cancer (MBC)
Herceptin is indicated for the treatment of patients with MBC whose tumours overexpress HER2:
- 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 post-menopausal patients with hormone receptor-positive MBC not previously treated with Herceptin.
Metastatic Gastric Cancer (MGC)
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 gastro-esophageal junction who have not received prior anti-cancer 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 FISH result, or IHC 3 , as determined by an accurate and validated assay.
The European Summary of Product Characteristics provides comprehensive clinical, pharmacological and prescribing information about Herceptin.