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  • Conversation: FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

    • October 4, 2021 1:22 PM BST
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      FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

      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.
      The FDA granted BTD based on data from the DESTINY-Breast03 phase 3 trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the phase 3 trial showed that Enhertu reduced the risk of disease progression or death by 72% vs trastuzumab emtansine (T-DM1). Nearly all patients treated with Enhertu were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1.
      Enhertu is a HER2-directed antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo that has now been granted four Breakthrough Therapy Designations, including two in breast cancer
      A breakthrough therapy designation is given to accelerate the development and regulatory review of potential new medicines for serious condition that address a significant unmet medical need.
      Breast cancer remains the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2-positive.
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