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

Author: Vandana Singh | November 14, 2022 09:15am

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving AstraZeneca Plc (NASDAQ:AZN) - Merck & Co Inc (NYSE: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 (OTC: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.