FDA Approval For AstraZeneca - Daiichi's Enhertu Expands To Earlier Use In Metastatic Breast Cancer

  • The FDA has approved AstraZeneca plc AZN and Daiichi Sankyo's DSKYF Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer.
  • The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of therapy.
  • Also Read: Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer.
  • The approval was based on positive results from the DESTINY-Breast03 Phase 3 trial that showed Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.
  • Regulatory applications for Enhertu are currently under review in Europe, Japan, and several other countries for unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.
  • Price Action: AZN shares are down 3.28% at $64.56 during the market session on the last check Thursday.
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