FDA Approves Drug For Treatment Of Advanced Breast Cancer

Reuters  (12/16, Maddipatla) reports, “MacroGenics Inc said on Wednesday the U.S. Food and Drug Administration (FDA) had approved its drug Margenza in combination with chemotherapy for the treatment of an advanced type of breast cancer in patients who failed two or more prior therapies.” The company “said it was expecting to launch the drug in March.”   Cancer Network  (12/16, Slater) reports, “The approval was based on safety and efficacy results observed in the pivotal, randomized, open-label, phase 3 SOPHIA trial (NCT02492711).” This “trial compared margetuximab-cmkb plus chemotherapy to trastuzumab (Herceptin) plus chemotherapy in patients with HER2-positive metastatic breast cancer who had previously been treated with anti-HER2-targeted therapies.”