FDA Approves New Treatment Option for Adjuvant Treatment of Specific Type of Early Breast Cancer

December 20th, 2017

On December 20, 2017, the FDA approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer at high risk of recurrence.

News in brief

  • The approval is based on results of the Phase III APHINITY study, which showed adjuvant treatment with Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death compared to Herceptin and chemotherapy alone.
  • Despite significant advances in the treatment of HER2-positive early breast cancer, there is still a chance that cancer cells may remain in the body after surgery, and the cancer may return.
  • The goal of treating early breast cancer after surgery is to reduce the risk of the cancer coming back.
  • The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive).

Supporting Information

Sandra Horning, M.D.

“The goal of treating breast cancer early is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have a recurrence and progress to the metastatic stage. Today’s approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to significantly reduce the chances of their disease returning.”