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trastuzumab emtansine : ウィキペディア英語版
trastuzumab emtansine

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 DM1.〔(【引用サイトリンク】title=Trastuzumab emtansine )〕 Trastuzumab alone stops growth of cancer cells by binding to the HER2/neu receptor, whereas DM1 enters cells and destroys them by binding to tubulin. Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the toxin specifically to tumor cells.〔 The conjugate is abbreviated T-DM1.
In the EMILIA clinical trial of women with advanced HER2 positive breast cancer who were already resistant to trastuzumab alone, it improved median overall survival by 5.8 months (30.9 months vs. 25.1 months) compared to the combination of lapatinib and capecitabine.〔 Based on that trial, the U.S. Food and Drug Administration (FDA) approved marketing on February 22, 2013.
Trastuzumab emtansine was developed by Genentech, a subsidiary group of Roche, and is manufactured by Lonza. The planned cost is expected to be $9,800 a month, or $94,000 for a typical course of treatment.〔
==Uses==
In the United States, ado-trastuzumab emtansine was approved specifically for treatment of HER2-positive metastatic breast cancer (mBC) in patients who have been treated previously with trastuzumab and a taxane (paclitaxel or docetaxel), and who have already been treated for mBC or developed tumor recurrence within six months of adjuvant therapy.〔U.S. FDA. . Retrieved 2012-02-23.〕
Approval was based on the EMILIA study, a phase III clinical trial that compared trastuzumab emtansine versus capecitabine (Xeloda) plus lapatinib (Tykerb) in 991 people with unresectable, locally advanced or metastatic HER2-positive breast cancer who had previously been treated with trastuzumab and taxane chemotherapy. This trial showed improved progression-free survival in patients treated with trastuzumab emtansine (median 9.6 vs. 6.4 months), along with improved overall survival (median 30.9 vs. 25.1 months) and safety.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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