Posted by Michael Wonder on 20 Dec 2019
MacroGenics announces submission of margetuximab biologics license application to U.S. FDA
19 December 2019 - MacroGenics today announced that the Company has submitted a biologics license application for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2.
The margetuximab submission is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology annual meeting, with updated data recently presented at the 2019 San Antonio Breast Cancer Symposium.
The SOPHIA study is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies.
