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March 8, 2018

The US Food and Drug Administration’s Approval of Adjuvant Sunitinib for Renal Cell CancerA Case of Regulatory Capture?

Author Affiliations
  • 1Institute of Cancer Policy, King’s College, London, England
  • 2Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston
  • 3Davidoff Cancer Center, Rabin Medical Center, Petach Tikvah, Israel
JAMA Oncol. Published online March 8, 2018. doi:10.1001/jamaoncol.2017.5697

On November 16, 2017, the US Food and Drug Administration (FDA) approved sunitinib as adjuvant treatment for patients with resected renal cell carcinoma (RCC) who are at a high risk of relapse. Questions are currently being asked regarding whether this was an appropriate approval. In this Viewpoint, we examine the data and circumstances behind the FDA approval.

This approval was considered by the FDA’s Oncologic Drugs Advisory Committee (ODAC) in September 2017. The voting was split, with 6 of 12 members voting “yes” and the remaining 6 members voting “no.” The data for the benefit of adjuvant sunitinib therapy come from the randomized, double-blind, phase 3 S-TRAC trial that compared 1 year of adjuvant sunitinib therapy vs placebo among patients with resected locoregional RCC at high risk for disease recurrence.1 The primary end point was disease-free survival (DFS), defined as the interval between randomization and the first tumor recurrence, the occurrence of metastasis or a secondary cancer, or death. In this trial, the median DFS with sunitinib therapy was 1.2 years longer than that with placebo (6.8 vs 5.6 years; hazard ratio, 0.76). Importantly, however, the overall survival (OS) (defined as the interval between randomization and death from any cause) showed no difference between adjuvant sunitinib and placebo with 8 years of follow-up (hazard ratio, 1.01). An examination of the Kaplan-Meier curves shows that they are so closely superimposed on each other that it is difficult to even distinguish that there are 2 curves. Intriguingly, these OS data were absent from the abstract and the nearly collinear OS curves were not visible in the main text of the New England Journal of Medicine article,1 but published only in the Supplement. In the initial presentation of these data at the annual meeting of the European Society for Medical Oncology in 2016, the lead investigator stated that the OS data were immature, and therefore did not show the OS curves.

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