AstraZeneca’s Enhertu and Imfinzi Approved in the EU

AstraZeneca (LON: AZN) announced Friday that it has secured European Union (EU) approval for two of its key cancer drugs, Enhertu and Imfinzi, in separate indications.

Enhertu, developed in partnership with Daiichi Sankyo, has been approved as the first HER2-directed therapy for patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who have received at least one endocrine therapy. 

The decision follows results from a Phase III trial, which is said to have demonstrated that Enhertu outperformed chemotherapy, offering patients a median progression-free survival of 13.2 months compared to 8.1 months with chemotherapy.

“This approval introduces a new treatment option for HR-positive metastatic breast cancers that express HER2,” said Professor Giuseppe Curigliano, principal investigator for the trial.

Meanwhile, AstraZeneca’s Imfinzi has been approved for use in resectable non-small cell lung cancer (NSCLC) in combination with chemotherapy. 

The decision is based on findings from the AEGEAN Phase III trial, which showed a 32% reduction in the risk of recurrence, progression, or death compared to neoadjuvant chemotherapy alone.

Professor Martin Reck, a key investigator in the trial, described the approval as “an important new treatment option” for patients facing historically high rates of recurrence.

Both approvals mark significant milestones for AstraZeneca as it expands its oncology portfolio in Europe.

AstraZeneca shares are down around 0.5% on Friday, trading around the 11,336p mark.