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MacroGenics announces FDA approval of Margenza for patients with pretreated metastatic HER2-positive breast cancer.

Read time: 1 mins
Published:18th Dec 2020
MacroGenics, Inc. announced that the 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. Margenza is the first product approved from MacroGenics’ promising pipeline. The approval was based on safety and efficacy results from the pivotal Phase III SOPHIA trial. The approval for Margenza was based on data from SOPHIA, a randomized Phase III clinical trial. The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio [HR]=0.76; 95% CI, 0.59-0.98; P=0.033; median PFS 5.8 vs 4.9 months). The objective response rate for Margenza plus chemotherapy was 22% and for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021.
Condition: Breast Cancer HER2+
Type: drug

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