Priority Review Granted for Adjuvant Combination Treatment for HER2-Positive 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, in combination with trastuzumab and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer.
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 4805 people with operable HER2-positive early breast cancer.
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.