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FDA Approves MacroGenics' Margenza For Pretreated Metastatic HER2-Positive Breast Cancer

MacroGenics Inc. (MGNX) said Wednesday that the U.S. Food and Drug Administration 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 company anticipates that Margenza will be available in March of 2021.

The approval for Margenza was based on safety and efficacy results from the pivotal Phase 3 SOPHIA 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.

The company said that the objective response rate for Margenza plus chemotherapy was 22% and for trastuzumab plus chemotherapy was 16%. The final overall survival analysis is expected in the second half of 2021.

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