AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Approved for NHS Use in England

AstraZeneca (AZN) and Daiichi Sankyo's Enhertu showed a 6-month progression-free survival extension in a Phase III trial for HER2-mutant lung cancer, with a 37% reduced risk of disease progression or death. Median PFS was 14.3 months vs. 8.3 months for standard treatment. The trial enrolled patients with advanced non-small cell lung cancer. Enhertu's safety profile was consistent with prior data, with no new concerns. The drug is already approved for certain metastatic cancers.

AstraZeneca's tozorakimab showed a lower annualized rate of moderate/severe COPD exacerbations vs. placebo in two phase 3 trials, according to data in The New England Journal of Medicine. The trials included over 1,700 patients with COPD and a history of exacerbations. The drug demonstrated efficacy across blood eosinophil counts and smoking status, with a favorable safety profile. AstraZeneca anticipates an FDA decision in Q1 2027.

The European Medicines Agency's CHMP recommended approval of AstraZeneca's Enhertu for early breast cancer treatment, potentially making it a new standard of care. The drug generated $1.8bn in 2025 revenue. The EMA also recommended approval for Klygefa, another AstraZeneca medicine. AstraZeneca shares were down 0.7% Monday, despite a 2.4% gain on Friday following the announcements.

AstraZeneca (LON: AZN) received positive opinions from the CHMP for Enhertu and Klygefa. Enhertu showed a 53% reduction in disease recurrence risk in a Phase III trial, while Klygefa improved symptoms in myasthenia gravis patients. Both drugs await European Commission approval, which could expand existing markets.

AstraZeneca and Daiichi Sankyo received a positive opinion from the European Medicines Agency's CHMP for Enhertu as an adjuvant monotherapy for HER2-positive early breast cancer. The recommendation, based on the DESTINY-Breast05 trial, shows Enhertu reducing the risk of invasive disease recurrence or death by 53% versus T-DM1. If approved, Enhertu could redefine adjuvant care and strengthen AstraZeneca's oncology position.

AstraZeneca's Alexion unit received a positive EU recommendation for Klygefa, a treatment for generalized myasthenia gravis. The approval is based on Phase III trial results showing significant improvements. If approved, Klygefa would be the first of its kind in the EU, expanding AstraZeneca's rare disease portfolio. The drug is already approved in Japan and under review in other markets.