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Lynparza Gets US OK For Pancreatic Cancer

FDA Says Yes To Third Cancer Type

Executive Summary

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AZ's Lynparza Shines Again In Prostate Cancer Study

With a PDUFA date fast approaching, AstraZeneca has presented more data from the PROfound study, this time showing that Lynparza improved OS compared to hormonal therapies in men with advanced castration-resistant prostate cancer with BRCA1/2 or ATM mutations.

AZ's Lynparza Gets Prostate Cancer Priority Review

The race is firmly on to be the first PARP inhibitor approved for metastatic castration-resistant prostate cancer, with the FDA giving a speedy review to AstraZeneca and Merck & Co's Lynparza just days after granting the same to Clovis Oncology's Rubraca.

US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

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