トラスツズマブ（遺伝子組換え）

来歴Trastuzumab, marketed as Herceptin, is a humanized monoclonal antibody whose history is a paradigm of breakthroughs in targeted therapy in oncology. Its development involves a close integration of basic scientific discoveries, clinical validation, and drug engineering. The story begins in the mid-1980s when Axel Ullrich, in his research team at Genentech, successfully cloned the HER2 (human epidermal growth factor receptor 2) gene, revealing its role in cell growth and proliferation. Subsequently, research by Dennis J. Slamon at UCLA showed that the HER2 gene was amplified and overexpressed in approximately 25% to 30% of breast cancer patients, and this overexpression was significantly associated with disease aggressiveness, high recurrence rates, and poor prognosis. This discovery provided a clear molecular target for targeted therapy. Subsequently, Genentech scientists, particularly H. Michael Shepard and colleagues, developed a monoclonal antibody that specifically binds to and blocks the activity of the HER2 receptor based on this target. Through drug engineering optimization, trastuzumab was finally developed, which can effectively inhibit the growth of HER2-overexpressing tumor cells. After years of clinical trials, trastuzumab was approved by the U.S. Food and Drug Administration (FDA) on September 25, 1998, for the treatment of HER2-positive metastatic breast cancer.

使用Trastuzumab is used to treat breast cancer. It is effective against tumors that overexpress the HER2/neu protien. As part of chemotherapy regimen for adjuvant treatment of lymph-node positive, HER2/neu positive cancer.