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Herceptin Phase III early adjuvant data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech halts two Phase III trials of Herceptin (trastuzumab) as adjuvant therapy in women with early HER2 positive breast cancer following positive interim results. A preliminary analysis of the National Cancer Institute-sponsored trials found Herceptin provided an improvement in the primary endpoint of disease-free survival as well as the secondary endpoint of overall survival. "We will work…to prepare these data for discussion with the FDA about a filing for Herceptin in the adjuvant setting based on this interim analysis," Genentech said. Novartis is planning an sNDA for use of Femara (letrozole) in the early adjuvant breast cancer setting in the second quarter (1Pharmaceutical Approvals Monthly February 2005, p. 5)...

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