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New Drugs Approved In December

Margenza
Margenza

The FDA green lighted Margenza, developed by MacroGenics, Inc. (MGNX) , on December 16, 2020.

Margenza (margetuximab-cmkb), in combination with chemotherapy, is indicated 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 drug comes with boxed warning about left ventricular dysfunction and embryo-fetal toxicity.

AstraZeneca and Daiichi Sankyo’s Enhertu, Seagen’s Tukysa and Puma’s Nerlynx are some of the competing therapies for Margenza.

MacroGenics expects to make the drug available in the market in March.