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Promising T-DM1 clears Phase III cancer study and marches on to the FDA

from FierceBiotech

Genentech's closely-watched breast cancer drug T-DM1 passed the goal line on its primary endpoint for significantly improved overall survival among metastatic patients, highlighting its prospects for a near-term FDA approval as parent company Roche preps for a filing with the EMA. The OS results add to the promising Phase III data on progression-free survival when compared to patients taking a combination of lapatinib and Xeloda, and that group will now have the option to be switched to T-DM1. While not surprising, the positive progress of T-DM1 is encouraging analysts to predict a near-certain regulatory approval in the first half of 2013. And the data can only further add to the reputation for antibody-drug conjugates, which have become one of the hottest fields in cancer drug research. more


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