The European Commission has approvedAstraZeneca Plc AZN – Daiichi Sankyo’sDSKYFDSNKY 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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