NICE Issues Final Draft Guidance Recommending Enhertu (Trastuzumab Deruxtecan) for Routine NHS Use in HER2-Low Advanced or Metastatic Breast Cancer After Chemotherapy Progression
The UK's National Institute for Health and Care Excellence (NICE) issued Thursday September 17, 2026 final draft guidance recommending Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan, HER2-targeted antibody-drug conjugate combining an anti-HER2 antibody with a topoisomerase I inhibitor payload via a cleavable linker) for routine National Health Service use in adults with HER2-low advanced or metastatic breast cancer whose disease has progressed after prior chemotherapy. The NICE recommendation is based on DESTINY-Breast04 Phase 3 data documenting a 6.4-month improvement in median progression-free survival and a 6.6-month improvement in median overall survival versus physician's choice chemotherapy in HER2-low mBC. This is one of the last major geographies to add routine HER2-low mBC coverage for Enhertu, which has been approved by the FDA (August 2022 HER2-low, January 2025 HER2-ultralow) and the EMA. The NICE reversal follows an earlier draft rejection based on cost-effectiveness concerns; the final recommendation reflects updated commercial arrangements with AstraZeneca-Daiichi Sankyo through the NHS.