AstraZeneca-Daiichi Sankyo's Enhertu wins EU nod for breast cancer

Cambridge, U.K.-based AstraZeneca PLC and Tokyo-based Daiichi Sankyo Co. Ltd. secured the European Commission's approval for Enhertu to treat certain breast cancer patients.

Enhertu, or trastuzumab deruxtecan, can now be used in the EU as a single therapy for adults whose breast cancer expresses the human epidermal growth factor receptor 2, or HER2, protein and cannot be removed through surgery or has spread to other parts of the body. These patients were previously treated with two or more anti-HER2-based regimens.

The approval was supported by the results of a mid-stage study called Destiny-Breast01, in which certain breast cancer patients who received Enhertu demonstrated a reduction in their tumor size. The European Medicines Agency recommended the approval of Enhertu in December 2020.

There are about 531,000 diagnosed cases of breast cancer in women annually in Europe, with one in five cases estimated to be HER2-positive, the companies noted in a news release.

AstraZeneca and Daiichi Sankyo are developing Enhertu under a $1.35 billion collaboration. Following the EU approval for breast cancer, AstraZeneca will make a milestone payment worth $75 million to Daiichi Sankyo.

Recently, the U.S. Food and Drug Administration approved the use of Enhertu to treat certain patients with advanced gastric cancer.