In late 2017, the US Food and Drug Administration (FDA) approved adjuvant sunitinib for patients with renal cell carcinoma (RCC) at high risk of recurrence post-nephrectomy.1 The approval is, however, controversial among some physicians, who argue that the overall survival (OS) and disease-free survival (DFS) data do not justify the FDA’s decision.

Bishal Gyawali, MD, PhD, is a medical oncologist from Nepal with experience in cancer care in both low- and high-income countries. He obtained his PhD from Japan as a MEXT scholar and is now working as a research fellow at Brigham and Women’s Hospital at Harvard Medical School in Cambridge, Massachusetts.

Cancer Therapy Advisor asked Dr Gyawali, who coauthored a viewpoint just published in JAMA Oncology, to discuss the FDA’s approval of sunitinib, and whether it is an example of what he calls “regulatory capture” in medicine.2

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Cancer Therapy Advisor (CTA): What is regulatory capture, and how is the FDA’s approval of adjuvant sunitinib an example of it?

Dr Gyawali: In any policy decision, there are some stakeholders with high-stake interest. Other stakeholders who don’t share these interests are less energized about the outcome of these decisions, while high-stake interest stakeholders are actively energized to have a decision in favor of their interest. Regulatory policy decisions can be influenced in this way, which is called regulatory capture.

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In the case of adjuvant sunitinib in RCC, high-stake interest groups tried to influence the policy decision by highlighting the DFS benefit and burying OS curves in a supplementary appendix.

People with low-stake interest, however, didn’t bother to dig through the data, search for data from another ASSURE trial, or look at the meta-analysis. The FDA decision to grant approval could, therefore, be a case of regulatory capture as the industry influenced the regulatory agency charged with regulating the industry in question.

CTA: Could you, in brief, describe the data that led to the approval of sunitinib for RCC in the adjuvant setting?

Dr Gyawali: There are 2 important trials that tested sunitinib for RCC in the adjuvant setting: the ASSURE and S-TRAC trials ( Identifiers: NCT00326898 and NCT00375674, respectively).

OS was not improved in both. DFS was also not improved in ASSURE but improved in S-TRAC; I previously did a meta-analysis of these 2 trials, which showed that adjuvant sunitinib actually doesn’t improve DFS or OS but increases the risks of grade 3 or higher adverse effects.3

The FDA, however, clearly gave more importance to the S-TRAC trial and approved sunitinib on the basis of positive DFS in that trial.

As our viewpoint discusses, it seems some of the ODAC [Oncology Drug Advisory Committee] members were also not aware that OS in the S-TRAC trial was actually negative, as the OS curves in the primary publication of S-TRAC trial were buried in the supplementary appendix.