Enhertu recommended for approval in the EU by CHMP for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen
Recommendation based on DESTINY-Breast03 trial results showing AstraZeneca and Daiichi Sankyo's Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1)
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been recommended for approval 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast03 Phase III trial, which were published in The New England Journal of Medicine .1 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<0.0001) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
In Europe, more than 530,000 cases of breast cancer are diagnosed annually.2 Approximately one in five cases of breast cancer are considered HER2-positive.3 Despite initial treatment with trastuzumab, pertuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.4,5 More treatment options are needed to further delay progression and extend survival.4,6,7
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This recommendation reflects the transformative progression-free survival benefit seen in the DESTINY-Breast03 trial compared to T-DM1, supporting Enhertu as a potential new standard of care and setting a new benchmark in the treatment of HER2-positive metastatic breast cancer . I f approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their disease, improving their chance for better outcomes.”
Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: “Today's CHMP opinion provides further validation of the significance of the DESTINY-Breast03 trial results, which for the first time showed superiority of Enhertu in prolonging progression-free survival in patients previously treated for HER2-positive metastatic breast cancer as compared to another HER2-directed ADC. This positive CHMP opinion is an important step forward in bringing this potentially practice-changing medicine to patients in Europe to use earlier in the treatment of HER2-positive metastatic breast cancer and builds on the recent approval of Enhertu in the US.”
The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorisations for medicines in the EU.
Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.