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MacroGenics seeks US FDA approval for breast cancer drug


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MacroGenics seeks US FDA approval for breast cancer drug

Rockville, Md.-based MacroGenics Inc. filed an application with the U.S. Food and Drug Administration for approval of margetuximab to treat certain breast cancer patients.

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The company's biologics license application of margetuximab is for treating previously treated patients with HER2-positive breast cancer whose cancer has spread to other organs of the body, in combination with chemotherapy.

The application is supported by data from a late-stage study, dubbed Sophia, which showed that patients receiving the combination experienced a slower progression of the disease compared to Roche Holding AG's Herceptin, or trastuzumab. The combination was also better in shrinking the size of the tumors.

Margetuximab is an investigational monoclonal antibody, designed to block HER2, which can propagate the growth of cancer cells, and enhance the engagement of the immune system.