Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

  • The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo DSKYF and AstraZeneca Plc's AZN Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.
  • The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of adjuvant chemotherapy. 
  • Related: AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting.
  • This is the third BTD for Enhertu in breast cancer. Enhertu previously received BTDs to treat second-line HER2 positive metastatic breast cancer in 2021 and later-line HER2 positive metastatic breast cancer in 2017.
  • Two additional BTDs for ENHERTU were also granted in 2020 for HER2 mutant non-small cell lung cancer and HER2 positive metastatic gastric cancer.
  • Price Action: AZN shares are up 2% at $66.36 during the premarket session on the last check Wednesday.

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