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[交流] 罗氏抗体-药物偶合新药上市,又一系列重磅开始?

Trastuzumab emtansine (INN; in the United States, ado-trastuzumab emtansine, trade name Kadcyla) is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab (Herceptin) linked to the cytotoxic agent mertansine (DM1).Trastuzumab alone kills cancer cells by binding to the HER2 receptor. The conjugate includes emtansine, which enters the cell and destroys the cell by binding to tubulin.Because monoclonal antibodies target HER2, and HER2 is only expressed in breast cancer cells, the conjugate delivers the toxin emtansine only to breast cancer cells.Meet the Bay Area's next blockbuster drug: T-DM1, a breast cancer-fighting treatment developed by Genentech Inc., leads the early Class of 2013 drugs seeking Food and Drug Administration approval. The FDA's decision date is Feb. 26.
In the EMILIA clinical trial of women with advanced HER2 positive breast cancer who were already resistant to trastuzumab alone, it improved survival by 5.8 months compared to the combination of lapatinib and capecitabine. Based on that trial, the U.S. FDA approved marketing on February 22, 2013.
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