SOPHIA Positions MacroGenics' Margetuximab For Role In HER2-Positive Breast Cancer
MacroGenics' BLA for full approval in the US is under way and the company already has established a manufacturing facility in preparation for a launch.
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US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.
MacroGenics Inc. will study the ability of margetuximab to enhance the immune system's destruction of HER2-positive tumors in a Phase Ib/II clinical trial to evaluate the monoclonal antibody in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) in advanced gastric cancer.