Taxotere Not Recommended For Approval In USA

The US Food and Drugs Administration's Oncologic Drugs Advisory Committee has recommended by a vote of 6-2 that Rhone-Poulenc Rorer's Taxotere (docetaxel) should not be recommended for the second-line treatment of breast cancer, and tied on a vote of whether to recommend the drug conditionally for the disease. The panel also voted by a majority of 8-0 that the drug should not be recommended for the second-line treatment of non-small cell lung cancer.

The company said that the trials presented in support of the breast cancer indication included 164 patients which demonstrated a response rate of 40%, with a median duration of six months. The panel said that the negative decision for breast cancer was based on the absence of sufficient toxicity data, and suggested that the company should continue with the trial to generate sufficient data to clarify the toxic effects of the drug.

With regard to the decision on non-small cell lung cancer, the panel said that it was the result of concerns over the safety of the drug in a general clinical setting.