Pertuzumab Granted Priority Review for Adjuvant Treatment of Early Breast Cancer
Genentech is seeking approval for Perjeta used in combination with trastuzumab and chemotherapy for adjuvant treatment of HER2-positive early breast cancer.
The FDA on Friday granted Priority Review to pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and chemotherapy for adjuvant treatment of HER2-positive early breast cancer.
Pertuzumab is designed to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3, and HER4) on the surface of cells, according to the press release.
The accepted supplemental Biologics License Application (sBLA) is based on data from the phase 3 APHINITY study, which included 4805 individuals with operable HER2-positive early breast cancer.
The randomized, double-blind, placebo-controlled, 2-arm study was designed to evaluate the safety and efficacy of pertuzumab plus trastuzumab and chemotherapy compared with trastuzumab and chemotherapy as adjuvant therapy.
The primary efficacy endpoint was invasive disease-free survival, defined as the time a patient lives without recurrence at any site or death from any cause after adjuvant treatment. Secondary endpoints included cardiac and overall safety, overall survival, disease-free survival, and health-related quality of life.
“We are pleased to receive Priority Review for the Perjeta-based regimen for the adjuvant treatment of HER2-positive early breast cancer,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in the 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 combination of pertuzumab, trastuzumab, and docetaxel chemotherapy is currently available in the United States under accelerated approval for neoadjuvant treatment of individuals with HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
Currently, no data has shown whether the treatment prior to surgery improves survival, according to the release.
The FDA is set to make a decision on approval by January 28, 2018.