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News From the Food and Drug Administration
February 4, 2020

Another Targeted Therapy for ERBB2-Positive Breast Cancer

JAMA. 2020;323(5):408. doi:10.1001/jama.2020.0222

The FDA recently granted accelerated approval to an antibody-drug combination for adults who’ve already received at least 2 treatment regimens for unresectable or metastatic breast cancer that is positive for human epidermal growth factor receptor 2 (ERBB2; formerly HER2/neu).

Marketed as Enhertu, fam-trastuzumab deruxtecan-nxki is an anti-ERBB2 antibody with a cytotoxic topoisomerase I inhibitor attached. It is administered via intravenous infusion. According to the FDA, about 20% of breast cancers have a genetic mutation that results in ERBB2-positive tumors, which are very aggressive.

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