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Research Letter | Health Care Reform

Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival An Analysis of 5 Years of US Food and Drug Administration Approvals

Chul Kim, MD, MPH1; Vinay Prasad, MD, MPH2
[+] Author Affiliations
1Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
2Division of Hematology and Medical Oncology, Knight Cancer Center, Oregon Health and Sciences University, Portland
JAMA Intern Med. 2015;175(12):1992-1994. doi:10.1001/jamainternmed.2015.5868.
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This review of approvals of cancer drugs based on a surrogate end point by the US Food and Drug Administration assesses the postmarketing findings for overall survival.

Most contemporary approvals of new cancer drugs are made on the basis of a surrogate end point, such as response rate or progression-free survival (PFS).1 When the approval is based on a surrogate end point, subsequent studies are advised and often obligated to clarify the drug’s effect on overall survival. One such drug is bevacizumab, which received accelerated approval on the basis of PFS for patients with metastatic breast cancer. Later findings revealed no improvement in overall survival and significant toxicity, which required a removal of marketing authorization.2

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Figure 1.
Oncology Drug Approvals Made on the Basis of a Surrogate End Point During the Study Period

The study period extends from January 1, 2008, through December 31, 2012. ALK indicates anaplastic lymphoma kinase; ALL, acute lymphoblastic leukemia; BCC, basal cell carcinoma; CLL, chronic lymphocytic leukemia; CML, chronic myeloid leukemia; CTCL, cutaneous T-cell lymphoma; DFS, disease-free survival; ERBB2 (formerly HER2 or HER2/neu), erb-b2 receptor tyrosine kinase 2; GIST, gastrointestinal stromal tumor; NET, neuroendocrine tumor; NHL, non-Hodgkin lymphoma; NSCLC, non–small cell lung cancer; PFS, progression-free survival; Ph, Philadelphia chromosome; RCC, renal cell carcinoma; and RR, response rate.

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Figure 2.
Overall Survival Results for Cancer Drug Approvals Granted on the Basis of a Surrogate End Point

Exact numbers of approvals depicted in this graph are given in the Results section.

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