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FDA defies advisers; OK's AZ's ovarian cancer drug Lynparza

This article was originally published in Scrip

Executive Summary

Even though the FDA's Oncologic Drugs Advisory Committee (ODAC) in June declined to back approval of AstraZeneca's Lynparza (olaparib), an oral inhibitor of polyadenosine 5-diphosphoribose polymerases, in ovarian cancer, the agency defied that advice and granted its blessing anyway on 19 December – although for a slightly different indication.


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