FDA approves Enhertu with pertuzumab for certain HER2-positive breast cancer

The Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki, or Enhertu from Daiichi Sankyo (DSNKY), in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer as determined by an FDA-approved test. FDA also approved the PATHWAY anti-HER-2/neu Rabbit Monoclonal Primary Antibody and HER2 Dual ISH DNA Probe Cocktail as companion diagnostic devices for selecting HER2-positive breast cancer patients for treatment with fam-trastuzumab deruxtecan-nxki in combination with pertuzumab.