FDA approves Taxotere for early stage breast cancer
The US FDA has approved Taxotere (docetaxel) Injection Concentrate in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant treatment of patients with operable, node-positive breast cancer.
The US FDA has approved Taxotere (docetaxel) Injection Concentrate in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant treatment of patients with operable, node-positive breast cancer.
French pharma company Aventis's supplemental New Drug Application (sNDA) received a Priority Review designation by the FDA, which is assigned to those applications that have the potential for providing a significant therapeutic advance. The additional indication also is under review by the European regulatory authorities.
The FDA based its decision on results from a second interim analysis from the pivotal Breast Cancer International Research Group (BCIRG) 001/TAX 316 study. This demonstrated that women with node-positive, early stage breast cancer who received a Taxotere-based chemotherapy regimen (TAC) after surgery experienced a 25.7% reduction in their risk of relapse compared with women treated with another adjuvant combination regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC).
Notably, with 55 months of follow-up, the significant reduction in the risk of relapse of this Taxotere-based regimen was observed regardless of a woman's hormone receptor status.