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An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the... Key PointsQuestionWhen the US Food and Drug Administration approves cancer drugs based on response rate (RR) (ie, the percentage of patients whose cancer shrinks beyond an arbitrary threshold), what is the RR? FindingsIn this review of 85 cancer drug indications approved on the basis of RR, the median RR was 41%. Of the 85 approvals, 14 (16%) had RR less than 20%, 28 (33%) had an RR less than 30%, and 40 (47%) had an RR less than 40%. MeaningMany cancer drugs are approved on the basis of low or modest RRs, typically in single-arm studies. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

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References (31)

Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2019.0583
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionWhen the US Food and Drug Administration approves cancer drugs based on response rate (RR) (ie, the percentage of patients whose cancer shrinks beyond an arbitrary threshold), what is the RR? FindingsIn this review of 85 cancer drug indications approved on the basis of RR, the median RR was 41%. Of the 85 approvals, 14 (16%) had RR less than 20%, 28 (33%) had an RR less than 30%, and 40 (47%) had an RR less than 40%. MeaningMany cancer drugs are approved on the basis of low or modest RRs, typically in single-arm studies.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Jul 28, 2019

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