Product Information for Study Drugs
Lapatinib
Lapatinib is an investigational drug for the adjuvant treatment of early breast cancer, but has been approved in the United States for treatment of metastatic disease. Specifically, lapatinib (Tykerb®) is approved in the United States in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. To view the US Full Prescribing Information for Tykerb®, click below:Tykerb® (lapatinib) PI–MBC–US only
Tykerb is a registered trade mark of the GlaxoSmithKline group of companies.
Trastuzumab
Trastuzumab (Herceptin®) is approved in the United States and Europe for the treatment of both early and metastatic breast cancer.
Adjuvant
Herceptin is approved for the adjuvant treatment of patients with HER2-overexpressing or HER2-amplifying, node-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)–as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel (US only).
Herceptin is approved for the adjuvant treatment of patients with HER2-overexpressing or HER2-amplifying, node-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)–as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel (US only).
Metastatic
In the US, Herceptin is approved for the treatment of patients with metastatic breast cancer (MBC) whose tumours overexpress the HER2 (ErbB2) protein–as a single agent in patients who have received one or more chemotherapy regimens for MBC; in combination with paclitaxel in patients who have not received chemotherapy for MBC (and for whom an anthracycline is not suitable in the EU); and, in the EU only, in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
In the US, Herceptin is approved for the treatment of patients with metastatic breast cancer (MBC) whose tumours overexpress the HER2 (ErbB2) protein–as a single agent in patients who have received one or more chemotherapy regimens for MBC; in combination with paclitaxel in patients who have not received chemotherapy for MBC (and for whom an anthracycline is not suitable in the EU); and, in the EU only, in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
To view the US Full Prescribing Information for Herceptin, click below:
Herceptin® (trastuzumab) PI–US
To view the EU Summary of Product Characteristics for Herceptin in English, click below:
Herceptin® (trastuzumab) PI–EU–English
For other European languages, see the Product Information links at the EMEA website:
http://www.emea.europa.eu/humandocs/Humans/EPAR/herceptin/herceptin.htm
Herceptin is a registered trade mark of Genentech, Inc.
Herceptin® (trastuzumab) PI–US
To view the EU Summary of Product Characteristics for Herceptin in English, click below:
Herceptin® (trastuzumab) PI–EU–English
For other European languages, see the Product Information links at the EMEA website:
http://www.emea.europa.eu/humandocs/Humans/EPAR/herceptin/herceptin.htm
Herceptin is a registered trade mark of Genentech, Inc.
