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# Enhertu Approved for HER2-low Breast Cancer
- URL: https://www.fdaweb.com/enhertu-approved-for-her2-low-breast-cancer/
- Published: 2022-08-05T12:00:00.000Z
- Updated: 2026-09-14T17:54:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152452

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](https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer?ref=fdaweb.com) says.

Approval was based on data from the [DESTINY-Breast04](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDQsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA4MDUuNjE4MzY1OTEiLCJ1cmwiOiJodHRwczovL2NsaW5pY2FsdHJpYWxzLmdvdi9jdDIvc2hvdy9OQ1QwMzczNDAyOT9kcmF3PTImcmFuaz0xJnRlcm09MDM3MzQwMjkmdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.u4d8e6IH-s8qRLZXdy%5FyrE06LjRMpoDivoPfFi7-ncM/s/1255931999/br/142144926088-l?ref=fdaweb.com) 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.”