AstraZeneca's Enhertu gets BTD for breast cancer; Centessa nabs $300M loan
The FDA has granted breakthrough designation to AstraZeneca’s and Daiichi Sankyo’s HER2 ADC Enhertu, the companies jointly announced today.
The BTD is 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.
Breakthrough therapy designation was based on data from the DESTINY-Breast03 pivotal trial at #ESMO21 just last month, which showed a 72% reduction compared to Roche’s ADC Kadcyla in the risk of disease progression or death in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
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