EU approves breast cancer drug Enhertu

pharmafile | January 20, 2021 | News story | Research and Development AstraZeneca, Daiichi Sankyo 

The EU has granted AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) conditional approval as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

The European Commission’s approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial, in which Enhertu showed clinically meaningful and durable anti-tumour activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens.

In the DESTINY-Breast01 Phase II trial, after a median follow-up of 20.5 months, the treatment showed a confirmed objective response rate of 61.4%, including a 6.5% complete response rate and a 54.9% partial response rate, and an estimated median duration of response of 20.8 months for patients with HER2-positive metastatic breast cancer who had received at least two previous lines of therapy.

Enhertu is being further assessed in several ongoing Phase III breast cancer trials as part of a broad development programme, including DESTINY-Breast02, a confirmatory trial in third-line HER2-positive metastatic breast cancer, and DESTINY-Breast03, as a second-line treatment. DESTINY-Breast04 is testing the drug in patients with metastatic breast cancer and low expression of HER2, and DESTINY-Breast05 is evaluating it as an adjuvant treatment of patients with high-risk HER2-positive early breast cancer.

Approximately 531,000 cases of breast cancer in women are diagnosed in Europe annually, with an estimated one in five cases being HER2-positive. Breast cancer is responsible for over 141,000 deaths in the continent every year.

Dave Fredrickson, Executive Vice President of the Oncology Business Unit, said: “Enhertu is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and this approval enables us to bring the benefits of this medicine to patients in the EU.

“We will continue to explore the potential of Enhertu in this setting, as well as in earlier lines of treatment and stages of disease, with the ambition of improving the lives of patients with HER2-targetable breast cancer.”

Gilles Gallant, Senior Vice President and Global Head of Oncology Development at Daiichi Sankyo, said: “This expedited review underscores the practice-changing potential of Enhertu for patients in the metastatic setting.

“Enhertu is the first-ever new medicine to be approved in breast cancer in Europe on the basis of Phase II single-arm data, and one of the fastest accelerated assessment procedures for an application in oncology.”

Darcy Jimenez

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