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FDA Approves Adjuvant T-DM1 in HER2+ Early Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, May 03, 2019

The FDA has approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for use as an adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant trastuzumab (Herceptin) and chemotherapy.1

T-DM1 was previously 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.

References

  1. FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment. Genentech. Published April 3, 2019. https://bit.ly/2UYWOVN. Accessed April 3, 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 [published online December 5, 2018]. New Engl J Med. doi: 10.1056/NEJMoa1814017.

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