Genentech's Trastuzumab Emtansine (T-DM1) Reduces The Risk Of Cancer Worsening
Date: Jun-04-2012Roche announced today that it's division, known as Genentech, has produced positive results in a phase three EMILIA study of a drug called trastuzumab emtansine (T-DM1). Genentech says that the drug met the endpoint target for the trial, showing marked improvement for women with HER2-positive metastatic breast cancer.
The study showed that the risks of the disease worsening or death of a patient taking their drug (T-DM1), was reduced by 35%, when compared with those on apatinib plus Xeloda® (capecitabine) chemotherapy (HR=0.65, pHerceptin® (trastuzumab) and a taxane chemotherapy.
The results of the EMILIA data will be presented during the plenary session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Kim Blackwell, M.D., Duke University School of Medicine (Abstract LBA1, Sunday, June 3, 1:45 p.m. CDT). The EMILIA data were also featured in the official ASCO press program on Saturday, June 2.
Hal Barron, M.D., chief medical officer and head, Global Product Development said that:
"The encouraging efficacy, safety profile and quality of life results from the EMILIA study support our belief that trastuzumab emtansine may have an important role for patients with HER2-positive metastatic breast cancer ... We are working with global regulatory authorities to submit these data as quickly as possible and hope that trastuzumab emtansine will soon be available to patients with this aggressive type of breast cancer."
Genentech and Roche say they plan to submit applications for trastuzumab emtansine in HER2-positive mBC this year to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Trastuzumab emtansine is an investigational medicine. What the drug does is basically attach the antibody trastuzumab to a chemotherapy DM1, using a stable linker. Thus, the medicine is delivered inside the cell cancer cells.
Written by Rupert Shepherd
View drug information on Herceptin; Xeloda.
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