Aventis Taxotere first-line indication
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Aventis Taxotere (docetaxel) receives approval Nov. 27 for first-line treatment of patients with unresectable locally advanced or metastatic non-small cell lung cancer in combination with cisplatin. Approval is based on a 1,218-patient clinical trial comparing Taxotere plus cisplatin or Taxotere plus carboplatin to a standard vinorelbine/cisplatin regimen. Median survival time for Taxotere/cisplatin was 10.9 months versus 10.0 months with the standard regimen. Taxotere/cisplatin yielded a 31.6% overall response compared to 24.4% for standard therap