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Herceptin early adjuvant sBLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech is requesting a priority review for its supplemental BLA for use of Herceptin (trastuzumab) in early adjuvant treatment of HER-2 positive breast cancer. Announced Feb. 15, the application includes data from two randomized Phase III trials showing that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of recurrence (1Pharmaceutical Approvals Monthly May 2005, In Brief)...

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