European Medicines Agency's Advisory Committee Backs Approval Of AstraZeneca's Three Cancer Drugs

European Medicines Agency's Advisory Committee Backs Approval Of AstraZeneca's Three Cancer Drugs
  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving AstraZeneca Plc AZNMerck & Co Inc MRK partnered Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for prostate cancer setting.
  • The opinion covers metastatic castration-resistant prostate cancer (mCRPC) patients for whom chemotherapy is not clinically indicated.
  • The CHMP also backed the approval of AstraZeneca’s Imfinzi (durvalumab) for the 1st-line treatment of unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
  • Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk of death by 24% vs. chemotherapy alone.
  • Related: FDA Approves AstraZeneca's Imfinzi/Imjudo Chemo Combo For Late Stage Lung Cancer.
  • AstraZeneca and Daiichi Sankyo’s DSNKY Enhertu (trastuzumab deruxtecan) has been recommended for approval as monotherapy for advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
  • Positive is based on DESTINY-Gastric02, which showed Enhertu demonstrated clinically meaningful efficacy, and DESTINY-Gastric01, which showed improved overall survival compared to chemotherapy.
  • Price Action: AZN shares are up 1.40% at $63.65 during the premarket session on the last check Monday.
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