Business
Enhertu granted BTD for breast cancer
Enhertu granted BTD for breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8763N\n AstraZeneca PLC\n 04 October 2021\n \n \n \n 4 October 2021 07:00 BST\n \n \n \n Enhertu\n \n \n granted Breakthrough Therapy Designation in US 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 Based on ground-breaking DESTINY-Breast03 results where Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1)\n \n \n \n \n \n Enhertu has now been granted four Breakthrough\n \n \n Therapy Designations, including two in breast cancer\n \n \n \n \n \n The Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan), Breakthrough Therapy Designation (BTD) in the US 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 HER2-directed antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo). \n \n \n \n \n \n The FDA granted BTD based on data from the DESTINY-Breast03 Phase III trial \n \n presented\n \n during the European Society for Medical Oncology (ESMO) Congress 2021. This is the second BTD for Enhertu in breast cancer and now brings the total number of BTDs to four for this medicine.\n \n \n \n \n The US FDA's BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.\n \n \n \n \n \n Breast cancer remains the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five cases of breast cancer are considered HER2-positive.2\n \n \n \n \n \n Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.3 More effective options are needed to further delay progression and extend survival.3-5\n \n \n \n \n \n Susan Galbraith, Executive Vi...