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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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Genentech's sBLA for adjuvant use of the breast cancer biologic Herceptin (trastuzumab) clears FDA Nov. 16. The new claim, for the adjuvant (post-surgery) treatment of patients with HER2-overexpressing, node-positive breast cancer as part of a regimen containing doxorubicin, cyclophosphamide and paclitaxel, is based on two National Cancer Institute Phase III studies. A European adjuvant indication approved in May is based on Roche's HERA trial; Genentech plans to file the HERA results, which support a less frequent dosing schedule, with FDA by the first quarter 2007. The approved sBLA was submitted in February and received a priority review (1Pharmaceutical Approvals Monthly March 2006, In Brief); the user fee goal of Aug. 17 was pushed back 90 days to review additional analyses and longer term data requested by the agency...

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