A cancer drug from AstraZeneca and Daiichi Sankyo called Enhertu, that reduces the risk of disease progression or even death by 72%, has been recommended for approval in the European Union (EU).
The drug containing trastuzumab deruxtecan is specifically engineered for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer treated with a prior anti-HER2-based regimen. It has been jointly developed and commercialized for the two companies.
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 3 trial, which were published in The New England Journal of Medicine.
Reduces disease progression
In the trial, Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
It is reported that in Europe alone, more than 530,000 cases of breast cancer are diagnosed every year. One in five is considered HER2-positive metastatic breast cancer.
Despite initial treatment with trastuzumab, pertuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression and research has proved more treatment options are needed to further delay progression and extend survival.
Susan Galbraith, executive vice president, oncology at 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.
“If 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.”
European commission review
The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
Enhertu is being further assessed in a comprehensive clinical development program evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Gilles Gallant, senior vice president, global head at 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 U.S.”
In 2018, the FDA gave AstraZeneca’s breast cancer drug, Lynparza, the go-ahead. This was targeted at women with advanced breast cancer that is specifically caused by mutations in the BRCA gene.