Lynparza Gets US OK For Pancreatic Cancer
FDA Says Yes To Third Cancer Type
The leading PARP inhibitor gets a new tumor type added to its label after a narrow ODAC vote in favor less than a fortnight ago.
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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.
AstraZeneca has got off to a strong start in 2020, with the FDA granting a fast review for its diabetes drug Farxiga in heart failure and China approving Lokelma for hyperkalemia.