FDA Approval Alert: Adjuvant Therapy for HER2-Positive Breast Cancer


The US Food and Drug Administration (FDA) has granted approval to an adjuvant therapy for human epidermal growth receptor 2 (HER2)-positive breast cancer at high risk of recurrence.

The FDA approved pertuzumab (Perjeta, Genentech), in combination with trastuzumab (Herceptin) and a pertuzumab-based chemotherapy regimen, for the adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.

Approval came following a risk reduction of invasive breast cancer recurrence or death by 18% for patients receiving pertuzumab plus trastuzumab-based chemotherapy compared with those receiving trastuzumab and chemotherapy alone (HR=0.82, 95% CI 0.67-1.00, P = .047).

Additionally, the FDA converted the previously-granted accelerated approval of the pertuzumab-based regimen to full approval in the neoadjuvant setting for HER2-positive, locally advanced, inflammatory, or early-stage breast cancer.

“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,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech, in a statement (December 20, 2017). “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 reduce the chances of their disease returning.”—Zachary Bessette