Aventis Taxotere

Executive Summary

Supplemental indication for docetaxel for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior platinum based chemotherapy approved Dec. 23. Labeling points out that "only one of the two [clinical] trials [for the NSCLC indication] showed a clear effect on survival," but notes that one-year survival rates favored Taxotere in both trials. Labeling also warns that the 100 mg/m2 dose was unacceptably toxic in trials for the NSCLC indication. Docetaxel is already approved for second-line treatment of locally advanced or metastatic breast cancer. The new indication was recommended for approval Dec. 13 ("The Pink Sheet" Dec. 20, 1999, p. 8)