KADCYLA® (Ado-trastuzumab Emtansine)

The FDA on May 3, 2019, approved KADCYLA® for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC), who have residual invasive disease after neoadjuvant Taxane and HERCEPTIN® (trastuzumab)-based treatment.KADCYLA® is a product of Genentech, Inc.

Patients should be selected based on an FDA-approved companion diagnostic for KADCYLA®. FDA also approved both the Ventana Medical Systems, Inc. PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay and the INFORM HER2 Dual ISH DNA Probe Cocktail assay as companion diagnostic devices for selecting patients.