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AstraZeneca and Daiichi Sankyo’s Enhertu receives EU approval

Specifically engineered antibody treats HER2-positive metastatic breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu – also known as trastuzumab deruxtecan – has been approved in the European Union (EU).

Enhertu is also a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. It is a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast03 phase 3 trial. In the study, Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.

Dave Fredrickson, executive vice president, Oncology Business Unit at AstraZeneca, explained: “With this approval, patients across Europe with HER2-positive metastatic breast cancer will have the opportunity to be treated with Enhertu even earlier in the treatment of their disease, improving their chance for better outcomes beyond what we can already offer patients treated in later-line settings.

“Today’s news is a further step in achieving our vision to continuously bring the transformative potential of Enhertu to patients as early as possible in their treatment to improve cancer outcomes.”

Ken Keller, global head of oncology business at Daiichi Sankyo, concluded: “We believe there is a significant need to transform outcomes for patients with HER2-positive metastatic breast cancer in Europe. In DESTINY-Breast03, treatment with Enhertu demonstrated superior progression-free survival and a doubling of the response rate compared to another HER2-directed ADC.

“With this approval we are now able to offer patients with HER2-positive metastatic breast cancer another option earlier in their treatment,” he added.

In Europe, more than 530,000 patients are diagnosed with breast cancer each year and approximately one in five patients with breast cancer are considered HER2-positive. Despite initial treatment with trastuzumab, pertuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.