AstraZeneca breast cancer drug wins US breakthrough therapy designation
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AstraZeneca said its breast cancer drug Enhertu had been granted breakthrough therapy designation (BTD) in the US.
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The Food and Drug Administration granted BTD based on data from a phase 3 trial presented during the European Society for Medical Oncology Congress 2021.
AstraZeneca said Enhertu demonstrated a 72% reduction in the risk of disease progression or death.
“This is the second BTD for Enhertu in breast cancer and now brings the total number of BTDs to four for this medicine,” the company said on Monday.
Enhertu is a HER2-directed antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo.