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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Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
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.