On Feb. 22, 2013,  the U.S. Food and Drug Administration (FDA) announced they had approved Genentech’s licensed ado-trastuzumab emtansine (Kadcyla) for use as a single agent for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination.

The clinical basis for licensure was a phase III trial in 991 patients with HER2-positive MBC that randomly allocated patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496).