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Comment & Response
November 2018

Information Transparency in the Drug Approval Process

Author Affiliations
  • 1Oncologic Drugs Advisory Committee, Food and Drug Administration, Washington, DC
  • 2Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio
  • 3Dana-Farber Cancer Institute, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 4Duke Cancer Institute, Durham, North Carolina
JAMA Oncol. 2018;4(11):1621-1622. doi:10.1001/jamaoncol.2018.4143

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