The U.S. Food and Drug Administration (FDA) has granted priority review to T-DM1 (chemical name: ado-trastuzumab emtansine), an experimental targeted therapy medicine, to treat HER2-positive, metastatic breast cancer.
T-DM1 is a combination of the targeted therapy medicine Herceptin (chemical name: trastuzumab) and the chemotherapy medicine emtansine. In T-DM1, the emtansine is attached to the Herceptin.
T-DM1 was designed to deliver emtansine to cancer cells in a targeted way by attaching emtansine to Herceptin. Herceptin then carries emtansine to the HER2-positive cancer cells.
Metastatic breast cancer is breast cancer that has spread to other parts of the body away from the breast, such as the bones or liver.
when they got T-DM1 compared to women who got a different targeted therapy regimen.
Priority review means that the FDA will review the approval application for T-DM1 within 6 months. According to Genentech, the company that makes T-DM1, the FDA action date is Feb. 26, 2013.
Stay tuned to Breastcancer.org for updates on the approval process for T-DM1.
Editor’s Note: On Feb. 22, 2013, the U.S. Food and Drug Administration (FDA) approved Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine). In some early studies on T-DM1, such as the study reviewed here, it was reported that the chemotherapy medicine maytansine was attached to Herceptin to form T-DM1. Emtansine is a derivative of maytansine.