AstraZeneca (AZN) and Daiichi Sankyo have secured a significant victory after their flagship antibody drug conjugate Enhertu was approved for NHS use in England and Wales.
The drug value assessor for England and Wales reversed course after previously rejecting the treatment in 2024, now deeming Enhertu cost effective for HER2-low advanced breast cancer patients.
Enhertu, widely regarded as one of the most important oncology drugs of its generation, has been a major commercial and clinical focus for both AstraZeneca and Daiichi Sankyo.
The HER2-low classification represents a significant and previously underserved patient population within the broader advanced breast cancer landscape.
Antibody drug conjugates, or ADCs, work by delivering targeted chemotherapy directly to cancer cells, reducing damage to surrounding healthy tissue compared with conventional treatments.
Enhertu has emerged as the leading ADC in the oncology space, with AstraZeneca having paid billions to co-develop and commercialise the drug alongside its Japanese partner Daiichi Sankyo.
The 2024 rejection had been a setback for both companies and for patients who had hoped to access the treatment through the NHS without bearing the cost privately.
Gaining a positive cost-effectiveness ruling from England and Wales’ drug assessor is a critical step toward making any new therapy routinely available on the NHS.
The approval reflects growing clinical evidence supporting Enhertu’s effectiveness in treating patients whose tumours express low levels of the HER2 protein, a group that had limited targeted treatment options previously.
The decision is expected to open access to Enhertu for a meaningful number of breast cancer patients across England and Wales who meet the HER2-low criteria.
For AstraZeneca, which is listed on the London Stock Exchange and Nasdaq, the ruling further strengthens the commercial case for its substantial investment in the ADC space alongside Daiichi Sankyo.