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 AZN - Merck & 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.
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