FDA Approval Sought for Margetuximab in HER2+ Metastatic Breast Cancer

December 20, 2019 – MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The BLA is based on data from the phase III SOPHIA trial. Data from a prespecified second interim OS analysis presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) showed that at a median follow-up of 15.6 months, the … (leggi tutto)