Herceptin (trastuzumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Herceptin (trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf. Revised March 2023. Accessed March 12, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) 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.	2
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) 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.	2
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.	2
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.	2
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).	2
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.	4
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.	2
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.	2
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult 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.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Docetaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Docetaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Carboplatin, Docetaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Carboplatin, Docetaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Doxorubicin, Paclitaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Doxorubicin, Paclitaxel, Trastuzumab
Sensitivity (+)	HER2-positive	Esophagogastric Adenocarcinoma	Capecitabine, Cisplatin, Trastuzumab
Sensitivity (+)	HER2-positive	Esophagogastric Adenocarcinoma	Cisplatin, Fluorouracil, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Esophagogastric Adenocarcinoma	Capecitabine, Cisplatin, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Esophagogastric Adenocarcinoma	Cisplatin, Fluorouracil, Trastuzumab