EU begins review of Enhertu as first-line treatment for breast cancer

The European Medicines Agency has initiated an evaluation procedure for the medicinal product Enhertu as a first-line treatment for HER2-positive breast cancer. This opens the possibility for approval in the European Union later this year, pharmaforum reports.

Manufacturers Daiichi Sankyo and AstraZeneca have submitted an application for Enhertu to be approved for use in combination with pertuzumab for newly diagnosed patients with unresectable or metastatic HER2-positive breast cancer. The application is based on the results of the DESTINY-Breast09 clinical trial.

Data from the study show a 44% reduction in the risk of disease progression or death compared to the current standard of first-line therapy—the combination of trastuzumab, pertuzumab, and taxane chemotherapy, known as THP.

The DESTINY-Breast09 study also investigated Enhertu as a monotherapy compared to THP, but so far the results do not show an advantage for the standalone application over the standard treatment.

Daiichi Sankyo and AstraZeneca have already received approval for this indication in the US, which was issued last month by the US Food and Drug Administration. The approval made the regimen the first new first-line therapy for HER2-positive metastatic breast cancer in more than a decade.

The new indication has the potential to drive Enhertu beyond the companies’ ambition to turn it into a product with annual sales exceeding $5 billion. For AstraZeneca, this is a key element of its strategy to reach total revenues of over $80 billion by 2030.

The US approval could also pave the way for even earlier use of the drug—in neoadjuvant and adjuvant settings. These possibilities are being explored in the DESTINY-Breast11 and DESTINY-Breast05 trials, the data from which were presented at the ESMO oncology congress last year. The two companies are also preparing applications for the use of Enhertu in a perioperative context for earlier stages of HER2-positive breast cancer.

Already established as a blockbuster therapy for advanced breast cancer and other indications, including gastric cancer, Enhertu generated revenue of $3.58 billion in the first half of this year—a 31% increase compared to the same period in 2024. This puts the drug on track to approach the $5 billion annual sales target as early as this year, even before the expansion of its use into earlier lines of treatment.

In Europe, approximately 557,000 new cases of breast cancer are diagnosed annually, with over 144,000 patients dying from the disease. HER2-positive metastatic breast cancer is an aggressive form that affects between 15% and 20% of patients with advanced disease.

Although targeted therapies against HER2 have improved treatment outcomes, the prognosis remains unfavorable. Most patients show disease progression within two years of starting first-line therapy with THP, and one in three patients does not reach subsequent treatment due to progression or death.