FDA Grants Pertuzumab Priority Review for HER2+ Early Breast Cancer

September 29, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pertuzumab for use in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer. The sBLA is based on data from the phase III APHINITY trial, which demonstrated that patients who received adjuvant pertuzumab along with trastuzumab plus chemotherapy had an invasive disease-free … (leggi tutto)