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Comment & Response
August 2017

Setting the Record Straight on FDA Approvals in Oncology

Author Affiliations
  • 1Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. 2017;177(8):1222. doi:10.1001/jamainternmed.2017.2241

To the Editor The Research Letter, “Quality of Life, Overall Survival and Costs of Cancer Drugs Approved Based on Surrogate Endpoints,”1 by Rupp and Zuckerman and the accompanying Editor’s Note “Improving the Accelerated Pathway to Cancer Drug Approvals”2 by Bauer and Redberg, both published in a recent issue of JAMA Internal Medicine, contain inaccuracies and misconceptions. Bauer and Redberg2 incorrectly state that Rupp and Zuckerman1 examined 18 oncology drugs that received accelerated approval (AA). A review of approval letters (http://www.accessdata.fda.gov/scripts/cder/daf) shows that among the 18 approvals and indications listed, 12 received regular approval (RA) with no postmarketing studies required to confirm benefit, 4 were granted AA and later RA after confirmation of benefit, 1 is under AA with confirmation pending, and 1 received AA with subsequent failure to confirm benefit.

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