27 June 2013 EMA/CHMP/751770/2012/corr1 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Herceptin International non-proprietary name trastuzumab Procedure No. EMEA/H/C/000278 Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E -mail
[email protected] Website www.ema.europa.eu An agency of the European Union Product information Name of the medicinal product: Herceptin Applicant: Roche Registration Ltd. 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom Active substance: trastuzumab International Nonproprietary Name/Common Name: trastuzumab Pharmaco-therapeutic group Monoclonal antibodies (ATC Code): (L01XC03) Therapeutic indications: Breast Cancer Metastatic Breast Cancer (MBC) 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.