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FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

October 4, 2021


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.

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