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FDA approves Perjeta-based regimen for adjuvant treatment of early breast cancer
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The FDA approved pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of patients with HER-2-positive early breast cancer at high risk for recurrence.
The FDA also granted full approval to use of that same regimen for neoadjuvant treatment of HER-2-positive, locally advanced, inflammatory or early-stage breast cancer. Until now, the neoadjuvant indication had been allowed under accelerated approval.
Pertuzumab (Perjeta, Genentech/Roche) — a HER-2/neu receptor antagonist — works with trastuzumab (Herceptin, Genentech/Roche) and docetaxel to inhibit HER-2 dimerization.
The FDA based the approval on results of the double-blind, randomized phase 3 APHINITY study, which evaluated the addition of pertuzumab to trastuzumab and chemotherapy as adjuvant therapy for 4,805 people with operable HER-2-positive early breast cancer.
Invasive DFS served as the primary endpoint. Secondary endpoints included overall and cardiac safety, DFS and health-related quality of life.
Median follow-up was 45.4 months.
As HemOnc Today previously reported, results showed significantly reduced risk for invasive breast cancer recurrence or death among patients assigned the pertuzumab regimen (HR = 0.82; 95% CI, 0.67-1).
The most common side effects associated with the pertuzumab regimen were nausea, diarrhea, hair loss, fatigue, nerve damage and vomiting. The most common grade 3 to grade 4 side effects were low levels of white blood cells with or without fever, decrease in red blood cells, decrease in certain types of white blood cells, diarrhea, fatigue, nausea, and mouth blisters or sores.
“The goal of treating breast cancer early is to provide people with the best chance for a cure. [Although] we come closer to this goal with each advance, many people still have a recurrence and progress to the metastatic stage,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “[This] approval of Perjeta means people with HER-2-positive early breast cancer at high risk [for] recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning.”