FDA approves two breast cancer regimens

The FDA has approved a taxane-based, non-anthracycline regimen consisting of Taxotere (docetaxel, from sanofi-aventis) and carboplatin combined with Herceptin (trastuzumab, from Genentech) (TCH) for the adjuvant treatment of HER2-positive early breast cancer. Another treatment, the AC-TH regimen, consisting of doxorubicin and cyclophosphamide followed by Taxotere and Herceptin was also approved.

Approvals were based on the BCIRG 006 clinical trial where both the TCH and AC-TH regimens were shown to significantly improved disease-free survival and overall survival compared to the AC-T (doxorubicin and cyclophosphamide followed by Taxotere) control regimen. Additionally, the risk of congestive heart failure was five-fold lower with the TCH regimen as compared to the AC-TH regimen.

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