Europe Approves AstraZeneca's Two Combo Therapies For Prostate, Bile Duct Cancer Settings

The European Commission has approved AstraZeneca Plc AZN and Merck & Co Inc's MRK Lynparza (olaparib) plus abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC) for patients for whom chemotherapy is not clinically indicated.
The approval was based on results from the PROpel Phase III trial.
In the trial, Lynparza combo therapy reduced the risk of disease progression or death by 34% versus abiraterone and prednisone or prednisolone, with a median radiographic progression-free survival of 24.8 months vs. 16.6 months.
A supplemental marketing application for Lynparza with abiraterone and prednisone or prednisolone is under FDA priority review for mCRPC. The Prescription Drug User Fee Act date is anticipated during the first quarter of 2023.
AstraZeneca will receive a regulatory milestone payment of $105 million from Merck.
The Commission has also approved AstraZeneca's Imfinzi (durvalumab) as 1st-line treatment for unresectable or metastatic biliary tract cancer in combination with chemotherapy.
Related: AstraZeneca Drug Imfinzi Fails As Monotherapy In Metastatic Lung Cancer Setting.
The approval was based on the primary results from the TOPAZ-1 Phase III trial. At the interim analysis, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.
Price Action: AZN shares are down 0.31% at $67.51 during the premarket session on the last check Wednesday.