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FDA Accepted Submission of Supplemental New Drug Application for LYNPARZA in Combination With Abiraterone and Prednisone or Prednisolone for Patients With Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone has been accepted and granted priority review by the U.S.

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AstraZeneca Announced Lynparza in Combination with Abiraterone Granted Priority Review in the US for Patients with Metastatic Castration-resistant Prostate Cancer

AstraZeneca's supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

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AstraZeneca Announced Enhertu Significantly Delayed Disease Progression in DESTINY-Breast02 Phase III Trial vs. Physician’s Choice of Treatment in Patients with HER2-positive Metastatic Breast Cancer

Positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu (trastuzumab deruxtecan) versus physician's choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated wi

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