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T-DM1 show overall survival advantage as Roche/Genentech make US and EU filings

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Executive Summary

Roche and its cancer specialist unit Genentech have announced that following the demonstration of an overall survival benefit in the Phase III EMILIA study, they will file for US and EU regulatory approval of the antibody-drug conjugate T-DM1 (trastuzumab emtansine). The filing had been widely expected since the antibody-drug conjugate – developed with cytotoxic and conjugation technology developed by Waltham, Massachusetts-based Immunogen - generated impressive progression-free survival results in EMILIA. Analysts are anticipating approval as early as the first quarter of 2013.

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