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Enhertu Approved in Europe for HER2-Low Metastatic Breast Cancer

NEW YORK – AstraZeneca and Daiichi Sankyo on Thursday said the European Commission approved Enhertu (trastuzumab deruxtecan) for patients with unresectable or metastatic HER2-low breast cancer.

The approval makes the drug available to patients deemed HER2-low via immunohistochemistry testing with scores of IHC 1+ or IHC 2+ and negative by in situ hybridization testing. Patients must have received prior chemotherapy treatment for metastatic breast cancer or developed recurrence within six months of completing adjuvant chemotherapy. The European approval follows a positive opinion from the Committee for Medicinal Products for Human Use in December based on results from the Phase III DESTINY-Breast04 trial.

In that study, treatment with Enhertu reduced the risk of disease progression or death by 50 percent compared to physician's choice of chemotherapy in patients with HER2-low metastatic breast cancer. Patients with hormone receptor-positive and -negative disease benefited from treatment. Median progression-free survival was 9.9 months for patients on Enhertu compared to 5.1 months for those on chemotherapy.

Daiichi Sankyo President and CEO Ken Keller said in a statement that the European approval "supports our vision to bring Enhertu to more patients across the HER2 spectrum, which requires a change to the breast cancer classification system that has been guiding treatment for more than two decades."

The European approval triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo. Enhertu was also recently approved in Canada in the same HER2-low breast cancer setting.