FDA Approval Sought for Adjuvant T-DM1 in High-Risk HER2+ Breast Cancer

February 5, 2019 – Genentech (Roche) has completed its FDA submission of a supplemental Biologics License Application (sBLA) for ado-trastuzumab emtansine (T-DM1) as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy. The sBLA is based on data from the phase III KATHERINE study, in which T-DM1 reduced the risk of invasive disease recurrence or death by 50% compared with … (leggi tutto)