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FDA Panel Tentative Yes To AZ’s Lynparza In Pancreatic Cancer

OS Data An Issue, EU Extension Also Under Review

Executive Summary

Lynparza doubled PFS in metastatic patients with germline mutations in BRCA but the FDA usually wants to see OS data before approving drugs for pancreatic cancer. Its advisory committee narrowly voted in favor of approval of the PARP inhibitor but will the agency follow suit?

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