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Enhertu approved in EU for HER2-positive mBC
Enhertu approved in EU for HER2-positive mBC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 19 July 2022 07:00 BST\n \n \n \n \n \n \n Enhertu\n \n \n approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens\n \n \n \n \n \n \n \n Approval broadens indication for AstraZeneca and Daiichi Sankyo's Enhertu across Europe to earlier use in HER2-positive metastatic breast cancer\n \n \n \n \n \n \n \n \n \n Based on ground-breaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1)\n \n \n \n \n \n \n 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.\n \n \n \n \n \n \n Enhertu\n \n is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.\n \n \n \n \n \n The approval by the European Commission (EC) follows the\n \n positive opinion\n \n 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\n \n The New England Journal of Medicine\n \n .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<0.000001) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.\n \n \n \n \n \n In Europe, more than 530,000 patients are diagnosed with breast cancer each year.2 Approximately one in five patients with 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\n \n \n \n \n \n Javier Cortés, MD, PhD, Head, International Breast Cancer Center (IBCC), Barcelona, Spain, said: \"This approval is an important milestone for patients and clinicians in Europe, since previously treated patients with HER2-positive metastatic breast cancer typically experienc...