AstraZeneca and Merck & Co report Lynparza setback in prostate cancer

16 December 2022

Big pharma pairing AstraZeneca (LSE: AZN) and Merck & Co (NYSE: MRK) announced a rare setback with their blockbuster PARP inhibitor Lynparza (olaparib) in prostate cancer on Thursday.

The US Food and Drug Administration (FDA) is to extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time to review the supplementary new drug application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone to treat metastatic castration-resistant prostate cancer (mCRPC).

In August of this year, the sNDA was granted Priority Review by the FDA, and the companies vowed that they would continue to work with the agency as it completes its analysis.

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