Despite questionable PARP data, FDA stamps quick OK on Lynparza as a frontline therapy for pancreatic cancer
FDA analysts picked apart the data, highlighted an absence of overall survival benefit and noted that AstraZeneca had yet to hit the mark required for earlier pancreatic cancer drug approvals — but it didn’t make any difference in the end. Shortly after a slight majority of expert advisers voted 7 to 5 in favor of using Lynparza as a maintenance therapy for germline BRCA-mutated metastatic adenocarcinoma of the pancreas after 16 weeks of dormancy, the FDA followed up with a formal sanction of its own on Monday.
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