FDA Approves Two New Uses for Trastuzumab in Treatment Regimens


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The Food and Drug Administration has approved two new uses for trastuzumab with hormone therapy in HER2 overexpressing, node-positive or high-risk node-negative breast cancer, the agency announced.

The new approvals are for use of trastuzumab (a) as part of a treatment regimen containing doxorubicin, cyclophosphamide, and docetaxel, and (b) as part of a regimen that includes docetaxel and carboplatin.

Genentech, which manufactures trastuzumab under the brand name Herceptin, submitted the two supplemental biologics license applications in June 2007 based on data from a Roche study that included an arm in which carboplatin was substituted for anthracyclines (doxorubicin and others) in an attempt to decrease the cardiotoxicity associated with that class.

Among other research, Genentech and Roche are studying trastuzumab in combination with bevacizumab for human growth factor receptor 2 (HER2)-positive first-line metastatic breast cancer and for adjuvant HER2-positive breast cancer.

Herceptin, which was first approved in 1998, is the first humanized antibody approved for the treatment of HER2-positive metastatic breast cancer. It is designed to target and block the function of HER2 protein overexpression, and is indicated as a first-line treatment with paclitaxel and as monotherapy in second- and third-line therapy.

In 2006, trastuzumab gained approval in a regimen containing doxorubicin, cyclophosphamide, and paclitaxel for adjuvant treatment. In January, Herceptin was approved as a single agent for adjuvant treatment of HER2 overexpressing node-negative and node-positive breast cancer following multimodality anthracycline-based therapy.

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