Posted by Michael Wonder on 17 Dec 2020
MacroGenics announces FDA approval of Margenza for patients with pretreated metastatic HER2 positive breast cancer
16 December 2020 - Product launch anticipated in March of 2021.
MacroGenics today announced that the U.S. FDA has approved Margenza, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
The approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial.
