Global pharma company AstraZeneca said on June 27 that its cancer drug Lynparza, developed with Merck & Co and Japan’s Daiichi Sankyo, developed with Enhartu, was recommended for the treatment of certain high-risk breast cancers in the European Union.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) have been approved for European Union (EU) recommendation as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have had one or Anti-HER2- over has been obtained. based regiments, AstraZeneca Blues in a release.
Enhertu is a specially engineered HER2-directed antibody drug conjugate (ADC) being developed and commercialized jointly by AstraZeneca and Daiichi Sankyo.
The European Medicines Agency’s (EMA) Committee on Medicinal Products for Human Use (CHMP) based its positive opinion on the results of the Destiny-Breast03 phase III trial, which was published in The New England Journal of Medicine.
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 HER2-positive unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and a taxane.
In Europe, more than 530,000 cases of breast cancer are diagnosed each year.2
AstraZeneca’s executive vice president of oncology R&D, Susan Galbraith, said: “This recommendation reflects the transformative progression-free survival benefit seen in the Destiny-Breast03 trial compared to T-DM1, which makes Enhartu a potential new standard of care. and 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 receive earlier benefits from this important drug in the treatment of their disease, can improve 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 recognition of the importance of the Destiny-Brest03 trial results, which for the first time in a long time, provided further recognition to the development of our community.” Progression-free survival in patients previously treated for HER2-positive metastatic breast cancer compared to another HER2-directed ADC. This positive CHMP opinion suggests this potentially practice-changing drug for patients in Europe is HER2- This is a significant step forward for earlier use in the treatment of positive metastatic breast cancer and builds on Enhartu’s recent approval in the US.”
The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for the drugs in the European Union.