FDA Approval for Trastuzumab
Brand name(s): Herceptin®
Approved for HER2-overexpressing breast cancer
Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.
On November 16, 2006, the U.S. Food and Drug Administration (FDA) granted approval to trastuzumab (Herceptin®, made by Genentech, Inc.) as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of women with node-positive, HER2-overexpressing breast cancer. The approval is based on evidence of a significant prolongation in disease-free survival in women receiving trastuzumab and chemotherapy compared to those receiving chemotherapy alone.
Brand name(s): Herceptin®
Approved for HER2-overexpressing breast cancer
Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.
On November 16, 2006, the U.S. Food and Drug Administration (FDA) granted approval to trastuzumab (Herceptin®, made by Genentech, Inc.) as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of women with node-positive, HER2-overexpressing breast cancer. The approval is based on evidence of a significant prolongation in disease-free survival in women receiving trastuzumab and chemotherapy compared to those receiving chemotherapy alone.
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