News >

Adjuvant T-DM1 Approaches EU Approval for HER2+ Early Breast Cancer

Jason M. Broderick @jasoncology
Published: Friday, Nov 15, 2019

Levi Garraway, MD, PhD

Levi Garraway, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.1

In the United States, T-DM1 is also approved for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant trastuzumab and chemotherapy.

References

  1. CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. Roche. Published November 15, 2019. https://bit.ly/2Xmhw4L. Accessed November 15, 2019.
  2. 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.
  3. von Minckwitz G, Huang C-S, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. 2019;380(7):617-628. New Engl Jour Med. doi: 10.1056/NEJMoa1814017.

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication
x