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Roche Files BLA For Conjugated Herceptin Follow-On Trastuzumab-DM1

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Roche's next-generation conjugated Herceptin could be on the market for HER2-positive breast cancer patients as soon as the first quarter of 2011, if the application gets a priority review. Roche's wholly owned subsidiary Genentech announced it had filed the trastuzumab-DM1 biologic license application July 7, asking for accelerated approval and a six-month review turnaround

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