AstraZeneca's Enhertu Wins European Approval For Pretreated Breast Cancer Setting

  • The European Commission has approved AstraZeneca Plc AZN and Daiichi Sankyo's DSNKY Enhertu as monotherapy for unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
  • The approval is based on results from the DESTINY-Breast03 Phase 3 trial, in which Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1).
  • Additional results from the DESTINY-Breast03 Phase 3 trial showed that in the secondary endpoint of overall survival (OS), there was a strong trend towards improved OS with Enhertu; however, this analysis is not yet mature and further follow-up is ongoing.
  • Related: Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer.
  • Nearly all patients treated with Enhertu were alive at nine months compared to 91.3% of patients treated with T-DM1. The confirmed objective response rate was more than doubled in the Enhertu arm versus the T-DM1 arm (79.7% vs. 34.2%).
  • Following EU approval, AstraZeneca will pay $75 million to Daiichi Sankyo as a milestone payment.
  • Price Action: AZN shares are up 1.46% at $67.34 during the premarket session on the last check Tuesday.
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