FDA accuses Sanofi of using misleading article

The US Food and Drug Administration has accused French drug major Sanofi-Aventis of circulating an article that contained misleading  statements about the comparable efficacy of Taxotere (docetaxel) for the  treatment of locally-advanced or metastatic breast cancer.

The reprinted article from the Journal of Clinical Oncology claims  Taxotere's superiority to paclitaxel on the basis of evidence that the  FDA has deamed "false or misleading." The agency ordered the firm, in an  April 16 letter, to stop using the reprinted information immediately and  to respond to its allegations.

The article presents efficacy results from two randomized comparator  trials that evaluated Taxotere in the treatment of locally-advanced or  metastatic breast cancer after failure of previous chemotherapy. In one  randomized trial, patients with a history of prior treatment with an  anthracycline-containing regimen were assigned to therapy with Taxotere  or the combination of mitomycin and vinblastine. The median time to  progression was 4.3 months for Taxotere versus 2.5 months for placebo  (p=0.01). In a second randomized trial, patients previously treated with  an alkylating-containing regimen were assigned to Taxotere or  doxorubicin. The median time to progression was 6.5 months for Taxotere  vs 5.3 months for doxorubicin.