To the Editor Drs Gyawali and Goldstein1 recently published a Viewpoint in which they accuse the US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) of being ignorant of overall survival (OS) data from the S-TRAC adjuvant sunitinib trial, and that this ignorance led to a recommendation for approval from 6 ODAC members and subsequently the FDA. They further accuse the sponsor of hiding the OS data in the Supplement of the full publication.2
Rini BI, Burstein HJ, George DJ. Information Transparency in the Drug Approval Process. JAMA Oncol. Published online September 06, 2018. doi:10.1001/jamaoncol.2018.4143
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