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Enhertu approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens.

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Published:19th Jul 2022

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

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast03 Phase III trial, which were published in The New England Journal of Medicine (previously cited). In the trial, Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p<0.000001) in patients with her2-positive unresectable and or metastatic breast cancer previously treated with trastuzumab and a taxane. as part of this approval, the ec has also extended the market protection period for enhertu in this setting by one extra year based on the significant clinical benefit compared to existing approved therapies.

Enhertu received a conditional EU approval to treat HER-2 positive breast cancer on 20 January 2021.

Condition: Breast Cancer HER2+
Type: drug

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