12/14/2004

United States of America - The Food and Drug Administration (FDA) has approved docetaxel (Taxotere®) for use in combination with doxorubicin and cyclophosphamide for the adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer, of which more than 300 000 women are diagnosed worldwide each year.

The FDA based its decision on results from a second interim analysis of the Breast Cancer International Research Group (BCIRG) study, which demonstrated that women with node-positive, early stage breast cancer who received a Taxotere®-based chemotherapy regimen (TAC) after surgery experienced a significant 25.7 percent reduction in their risk of relapse.

Docetaxel is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.

Among patients receiving docetaxel the most common severe adverse events were low blood cell count, fatigue, diarrhoea, and mouth and throat irritation. The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, dyspnoea, rash, nail changes, nausea, vomiting, and muscle pain. Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions. Patients 65 years of age or older may experience some side effects more frequently

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