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

• The FDA has approved AstraZeneca plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC: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.