Enhertu EU approval : Daiichi Sankyo, AstraZeneca get approval for HER2 low metastatic breast cancer

Daiichi Sankyo and AstraZeneca have received the approval of the European Union (EU) for their jointly developed Enhertu (trastuzumab deruxtecan) for the treatment of a type of breast cancer patients.

Enhertu has been approved as a monotherapy for the treatment of adult patients having unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer, who were treated previously with one or two prior lines of chemotherapy.

Enhertu EU approval for the indication was backed by the results from the DESTINY-Breast04 phase 3 trial wherein the HER2 directed antibody drug conjugate reduced the risk of disease progression or death by 50%. It also increased median overall survival by more than six months compared to physician’s choice of chemotherapy in patients having HER2 low metastatic breast cancer with hormone receptor (HR) positive or HR negative disease.

Ken Keller — Daiichi Sankyo President and CEO and Oncology Business Global Head, commenting on the Enhertu EU approval, said: “The approval of enhertu in HER2 low metastatic breast cancer represents a significant clinical advance for patients in Europe with both HR positive and HR negative disease who previously have had limited treatment options in the late-line setting.

“This milestone also 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.”

Daiichi Sankyo, AstraZeneca get Enhertu EU approval for HER2 low metastatic breast cancer. Photo courtesy of Dimitris Vetsikas from Pixabay.

AstraZeneca will make a milestone payment of $150 million to Daiichi Sankyo subsequent to the approval in the EU.

Designed using Daiichi Sankyo’s proprietary DXd antibody drug conjugate technology, enhertu is also jointly marketed by the two firms.

Daiichi Sankyo and the UK-based AstraZeneca entered into a global collaboration to jointly develop and commercialize enhertu and datopotamab deruxtecan (Dato-DXd) in March 2019 and July 2020, respectively.

The Japanese pharma company, however, is in charge of the manufacturing and supply of enhertu and datopotamab deruxtecan in Japan where the former maintains exclusive rights for each antibody drug conjugate.

In August 2022, AstraZeneca and Daiichi Sankyo bagged Enhertu FDA approval for the treatment of unresectable or metastatic HER2-low breast cancer.