FDA Approves New Adjuvant Treatment for Certain Patients with HER2-Positive Early Breast Cancer

May 3rd, 2019

On May 3, 2019, the FDA approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin®-based treatment.

News in brief

  • This approval is an important advance in HER2-positive EBC, based on results of the Phase III KATHERINE study showing adjuvant Kadcyla significantly lowered the chances of cancer coming back compared to Herceptin in people with HER2-positive EBC who had residual invasive disease after neoadjuvant taxane and Herceptin-based treatment
  • Kadcyla is Genentech’s first medicine approved under the FDA’s Real-Time Oncology Review (RTOR), which led to approval less than 12 weeks after completing the submission.
  • FDA also granted Kadcyla Breakthrough Therapy Designation for this indication, designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
  • Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.

Supporting Information

Sandra Horning, M.D.

"This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated. With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure."