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

Jason M. Broderick @jasoncology
Published: Tuesday, Feb 05, 2019

Dr. Sandra Horning

Sandra Horning, MD
Genentech (Roche) has completed its FDA submission of a supplemental Biologics License Application (sBLA) for ado-trastuzumab emtansine (T-DM1; Kadcyla) as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.

T-DM1 is currently approved by the FDA for the treatment of patients with metastatic HER2-positive breast cancer who previously received trastuzumab and a taxane, either alone or in combination.


  1. Geyer Jr CE, Huang C-S, Mano MS, et al. Phase III Study of Trastuzumab Emtansine(T-DM1) vs Trastuzumab as Adjuvant Therapy in Patients with HER2-Positive Early Breast Cancer with Residual Invasive Disease after Neoadjuvant Chemotherapy and HER2-Targeted Therapy Including Trastuzumab: Primary Results from KATHERINE (NSABP B-50-I, GBG 77 and Roche BO27938). Presented at: 2018 San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, TX. Abstract GS1-10.
  2. von Minckwitz G, Huang C-S, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer [published online December 5, 2018]. New Engl J Med. doi: 10.1056/NEJMoa1814017.

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