Monday, August 27, 2012
Genentech seeks approval of 'armed antibody' targeting breast cancer
Genentech Inc.’s one-two cancer-fighting punch – an antibody-drug conjugate called T-DM1 – extended the lives of women with a type of metastatic breast cancer compared to patients on another therapy, the South San Francisco-based company said Sunday. Genentech, the U.S. subsidiary of Swiss drug maker Roche, did not disclose a specific length of time by which T-DM1, or trastuzumab emtansine, extended the lives of HER2-positive metastatic breast cancer patients over a group of patients given a combination of the drugs Tykerb and Xeloda. Genentech said it has submitted a biologics license application, which is similar to a new drug application, for T-DM1 to the Food and Drug Administration. An FDA decision on the drug could come by mid-2013. The agency in 2010 refused to consider Genentech’s application for accelerated approval based on data from a Phase II study.