T-DM1 (Genentech) is filed at FDA for HER-2 positive metastatic Breast Cancer

Genentech/Roche has announced that the 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.