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FDA grants priority review to Perjeta-based regimen for HER-2-positive breast cancer
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The FDA granted priority review to pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of patients with HER-2-positive early breast cancer, according to the drug’s manufacturer.
The supplemental biologics license application included data from the randomized phase 3 APHINITY study.
The double-blind, placebo-controlled study evaluated the addition of pertuzumab (Perjeta, Roche) — designed to target the HER-2 receptor — to trastuzumab (Herceptin; Genentech) and chemotherapy in 4,805 women with operable HER-2-positive early breast cancer.
Invasive DFS served as the primary endpoint. Secondary endpoints included cardiac and overall safety, OS, DFS and health-related quality of life.
Researchers reported a higher invasive DFS rate at 3 years among women assigned pertuzumab, trastuzumab and chemotherapy than those assigned placebo plus trastuzumab and chemotherapy (94.1% vs. 93.2%; HR = 0.81; 95% CI, 0.66-1).
The estimated rate of invasive DFS at 4 years also was higher among those who received pertuzumab (92.3% vs. 90.6%).
The most common grade 3 or higher adverse events included neutropenia (16.3% for pertuzumab vs. 15.7% for placebo), febrile neutropenia (12.1% vs. 11.1%), diarrhea (9.8% vs. 3.7%), neutrophil count decrease (9.6% vs. 9.6%) and anemia (6.9% vs. 4.7%).
“We are pleased to receive priority review for the Perjeta-based regimen for the adjuvant treatment of HER-2-positive early breast cancer,” Sandra Horning, MD, chief medical officer and head of global product development of Roche, said in a company-issued press release. “The goal of treating breast cancer early is to provide people with the best chance for a cure. Despite advances in the treatment of this disease, many people treated with the current standard of care still see their cancer return.”
The FDA is expected to make a decision on the supplemental application by Jan. 28.
The combination of pertuzumab, trastuzumab and chemotherapy is available in the United States under accelerated approval for neoadjuvant treatment of HER-2-positive, locally advanced, inflammatory or early-stage breast cancer.