FDA Grants Priority Review for Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer
On September 29, Roche announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer. The FDA is expected to make a decision on approval by January 28, 2018.
The submission is based on the results of the phase III APHINITY study, an international, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of pertuzumab plus trastuzumab and chemotherapy compared with trastuzumab and chemotherapy as adjuvant therapy in 4,805 people with operable HER2-positive early breast cancer. The primary efficacy endpoint of the APHINITY study is invasive disease–free survival. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival, and health-related quality of life.
The combination of pertuzumab, trastuzumab, and chemotherapy is licensed as a neoadjuvant treatment for patients with HER2-positive early breast cancer in more than 85 countries worldwide following approvals by the European Medicines Agency and the FDA. In the United States, the regimen is currently available under the FDA Accelerated Approval program.
“We are pleased to receive Priority Review for the [pertuzumab]-based regimen for the adjuvant treatment of HER2-positive early breast cancer,” said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. “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 content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
