AstraZeneca - Daiichi Sankyo's Enhertu Wins European Approval For Gastric Cancer, CHMP Backs Other Cancer Drugs

  • The European Commission has approved AstraZeneca Plc AZNDaiichi Sankyo’s DSKYF DSNKY Enhertu (trastuzumab deruxtecan) for advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • The approval covers patients who have received a prior trastuzumab-based regimen.
  • Concurrently, the Committee for Medicinal Products (CHMP) for Human Use (CHMP) of the European Medicines Agency has backed the approval for Enhertu for unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
  • The CHMP also backed approving AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combinations for advanced liver and lung cancers.
  • The concurrent positive opinions recommend Imfinzi plus Imjudo for 1st-line treatment of advanced or unresectable hepatocellular carcinoma (HCC); and Imfinzi plus Imjudo plus platinum-based chemotherapy for Stage IV (metastatic) non-small cell lung cancer (NSCLC).
  • The CHMP also backed extending Forxiga (dapagliflozin) indication for heart failure with reduced ejection fraction (HFrEF) for patients across the full spectrum of left ventricular ejection fraction.
  • Price Action: AZN shares are down 0.56% at $67.68 during the premarket session on the last check Friday.
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