Enhertu Approved for HER2-low Breast Cancer

FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-low breast cancer. “This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer,” an agency release says.

Approval was based on data from the DESTINY-Breast04 clinical trial involving  a 557 adult patients with unresectable or metastatic HER2-low breast cancer. The results showed Enhertu improved both progression-free survival and overall survival, FDA says. “The most common adverse reactions in patients receiving Enhertu in DESTINY-Breast04 are nausea, fatigue, alopecia, vomiting, constipation, decreased appetite, musculoskeletal pain and diarrhea,” it says. “The prescribing information includes a boxed warning to advise health care professionals of the risk of interstitial lung disease and embryo-fetal toxicity.”