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Aventis Taxotere sNDA schedule for 2004

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aventis' March 18 sNDA submission for use of Taxotere in early-stage breast cancer with involved axillary lymph notes is the second of four supplements planned for 2004. The docetaxel sNDA is based on a Phase III trial showing a significant benefit for a Taxotere/doxorubicin/cyclophosphamide (TAC) regimen compared to the standard 5-fluorouracil/doxorubicin/cyclophosphamide regimen. At 55 months follow-up, TAC-treated patients showed a 30% mortality risk reduction and a 28% reduction in chance of recurrence. The early-stage breast cancer sNDA follows a Jan. 27 submission for metastatic hormone-refractory prostate cancer. Applications for advanced gastric cancer and neo-adjuvant treatment of head and neck cancer are expected by the end of 2004...
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