Industry Overview
In the second quarter of 2010, the U.S. Food and Drug Administration (FDA) approved Amgen’s Prolia™ (Denosumab), a monoclonal antibody to treat osteoporosis, which is expected by many industry professionals to become another antibody-based blockbuster therapy rather quickly. Genentech, a member of the Roche Group, submitted a Biologics License Application to the FDA for Trastuzumab-DM1 (T-DM1) to treat pretreated women with advanced HER2-positive breast cancer. The program is seen as a very promising representative of an antibody-drug conjugate, also known as an armed antibody. T-DM1 is the first DM-1-conjugated monoclonal antibody to be reviewed by the FDA. The submission is based on the results of a phase 2 study, which showed T-DM1 shrank tumors in one-third of the women who had received on average seven prior medicines for advanced HER2-positive breast cancer.