Lynparza Gets US OK For Pancreatic Cancer
FDA Says Yes To Third Cancer Type
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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.
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.