England Approves Enhertu for NHS Use, Expanding Access to Targeted Breast Cancer Treatment

Around 1,000 women in England each year are expected to gain access to Enhertu (trastuzumab deruxtecan), following a decision by the National Institute for Health and Care Excellence (NICE) to recommend the treatment for eligible patients with HER2-low advanced or metastatic breast cancer. Announced on September 17, 2026, the decision reverses a previous rejection and expands NHS access to a treatment that has demonstrated a significant survival benefit in clinical trials.
Enhertu, developed by AstraZeneca and Daiichi Sankyo, is an antibody-drug conjugate that combines a HER2-targeting antibody with a chemotherapy agent. Unlike conventional HER2-targeted therapies, which primarily benefit patients with high HER2 expression, Enhertu can target cancer cells expressing lower levels of the protein, expanding treatment possibilities for patients previously classified as HER2-negative.
The decision follows evidence from the Phase III DESTINY-Breast04 trial, involving 557 patients with previously treated HER2-low metastatic breast cancer. Median overall survival reached 23.4 months with Enhertu, compared with 16.8 months among patients receiving chemotherapy selected by their physician. Median progression-free survival was also longer, at 9.9 months versus 5.1 months, respectively.

Despite these results, NICE initially rejected Enhertu for this indication in July 2024, concluding that its cost was too high relative to its clinical benefits. The latest decision follows a new commercial agreement between the manufacturers and NHS England, alongside changes to NICE's cost-effectiveness thresholds and methods for assessing quality of life. The financial terms of the agreement have not been disclosed.
For oncologists, the decision expands treatment options for eligible patients whose disease has progressed following previous chemotherapy. Accurate HER2 testing remains essential to identifying patients who may benefit, particularly those with low HER2 expression who would previously have been considered unsuitable for HER2-directed treatment.
However, the clinical benefits must be balanced against potential adverse effects. In DESTINY-Breast04, drug-related interstitial lung disease or pneumonitis occurred in 12.1% of patients receiving Enhertu, including fatal events in 0.8%. Careful patient selection, monitoring, and timely management of suspected pulmonary toxicity remain important considerations.
Enhertu has been available to eligible patients in Scotland since 2023. AstraZeneca and Daiichi Sankyo are now pursuing access for this indication in Wales and Northern Ireland, potentially extending availability across the United Kingdom.
Reuters
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