September 24,2013 | By Márcio Barra
Kadcyla (ado-trastuzumab emtansine, or T-DM1), from Roche/Genentech, was approved on the September 2013 meeting of the EMA’s Committee for Medicinal Products for Human Use. This is the drug’s third approval in a major territory, following the US FDA’s approval back in February and in Japan for the treatment of HER2+ positive inoperable or recurrent breast cancer.
Kadcyla is a therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, consisting of the antibody trastuzumab, connected to a drug called DM1, from ImmunoGen. The medicine, which comes in two dosage forms, 100 mg and 160 mg, was approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and chemotherapy, separately or in combination.
HER2 is a protein encoded by ERBB2, a proto-oncogene located in chromosome 17. Over-expression of this proto-oncogene occurs in roughly 30% of breast cancers, and the increased amount of HER2 protein contributes to the breast cancer cell growth and survival.