Posted on: Sep 6, 2012 08:41AM
Just wanted to pass this on to any HER2+ survivors in case you haven't heard this. It seems encouarging:
On August 26, 2012, Genentech and Roche announced that results of a second interim analysis of overall survival from the EMILIA study showed that T-DM1 significantly improved survival of people with HER2-positive metastatic breast cancer (mBC) compared with those who received lapatinib and Xeloda® (capecitabine). The data will be presented at an upcoming medical meeting. In addition, Genentech submitted the T-DM1 application to the FDA on August 24, 2012. Genentech is requesting Priority Review. If Priority Review is granted it would result in a 6-month review time instead of the standard 10-month review. However, it is up to the FDA to determine if the application will receive Priority Review. Genentech is working to provide greater access to T-DM1 to people with HER2-positive metastatic breast cancer in urgent need prior to a potential approval. • Based on these updated survival results, people in the lapatinib and Xeloda arm of EMILIA will be offered the option to receive T-DM1 (cross-over). • In the United States, Genentech plans to open an Expanded Access Program (EAP) to provide, under certain circumstances, eligible people with advanced HER2-positive breast cancer access to T-DM1 while the company seeks regulatory approval. Genentech is working to open enrollment in the EAP as quickly as possible. Patients and doctors in the United States seeking information about access to one of Genentech’s investigational medicines should call Genentech’s Trial Information Support Line at 888-662-6728.