Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review. Trastuzumab emtansine’s proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. The FDA confirmed the action date is February 26, 2013.
“We are very pleased that the FDA has granted trastuzumab emtansine a Priority Review, as we know people with HER2-positive metastatic breast cancer still need new treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.
Roche’s Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive mBC has also been accepted for review by the European Medicines Agency (EMA).
About Trastuzumab EmtansineTrastuzumab emtansine is an antibody-drug conjugate (ADC) being studied in HER2-positive cancers. It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signaling and deliver the chemotherapy DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to HER2-positive cancer cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once trastuzumab emtansine is taken up by those cancer cells, it is designed to destroy them by releasing the DM1. Genentech licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc. Building on the results of trastuzumab emtansine studies to date, there are approximately 25 ADCs in Genentech and Roche’s pipeline. About Breast Cancer Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer. About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.