Trastuzumab - EPARs for authorised medicinal products for human use - Herceptin

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EPARs for authorised medicinal products for human use - Herceptin

Active Substance
Trastuzumab
International Nonproprietary Name or Common Name
Trastuzumab
Pharmaco-therapeutic Group
Antineoplastic agents
ATC Code
L01XC03

Therapeutic Indication:
Breast Cancer


Metastatic Breast Cancer (MBC)

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

a) 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.

b) 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.

c) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.

d) 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 (EBC)

Herceptin is indicated for the treatment of patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see Section 5.1).

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 (see Sections 4.4 and 5.1).

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 (see Sections 4.4 and 5.1).

Date of issue of Marketing Authorisation valid throughout the European Union
28 August 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use