CTA: Data from the 2018 Genitourinary Cancers (GU) Symposium indicate that elderly women may actually have an increased risk of death with adjuvant sunitinib. Do you expect, given the FDA approval, that the drug is likely to be prescribed despite this risk?

Dr Gyawali: This is the subgroup analysis from the ASSURE trial I mentioned before. It was surprising that ASSURE data weren’t given much consideration during the approval.

Continue Reading

In our meta-analysis, we did find a greater than 1 hazard ratio for OS, but this was not significant. So, there might be some patients who can actually be harmed by adjuvant sunitinib. Subgroup analysis can’t be considered definitive, though “first, do no harm” dictates against the use of a medication when there is a risk of harm.

If oncologists engage in shared decision-making, I guess most patients wouldn’t opt for this treatment after knowing the data. FDA approval, however, encourages practitioners and patients to use this drug without due consideration, as many assume FDA approval is equivalent to a better benefit-risk profile. This is also true for countries outside of US, where clinicians assume that FDA approval is the gold standard for evidence of efficacy.

CTA: What procedures might be put in place to reduce the risk of regulatory capture and the effects thereof?

Dr Gyawali: The FDA should be more proactive in vigilantly avoiding any such potential spins by the high-stake interest group, and should also ensure that the ODAC members have seen all the relevant data regarding the intervention in question.

Related Articles

CTA: Can you describe your notion of “cancer groundshot,” and enumerate the biggest shortcomings of the Moonshot project? In what areas of oncology do you think funding is lacking the most?

Dr Gyawali: In our essay, we propose the “cancer groundshot” as a parallel program rather than a replacement.4

Cost-effective and globally applicable interventions, as well as implementation of interventions we already know, need more funding — but have been ignored under the Moonshot project. Focusing only on “sexy interventions,” such as precision oncology, big data, or immunotherapy, is clearly not the solution to global cancer control.

Both the sunitinib paper and the cancer groundshot paper fall under the common theme of “sense in oncology,” as the current oncology policies and practices are likely driven more by money and hype than logic, common sense, or humanity.


  1. FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; November 16, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm585686.htm. Accessed March 2018.
  2. Gyawali B, Goldstein DA. The US Food and Drug Administration’s approval of adjuvant sunitinib for renal cell cancer a case of regulatory capture? JAMA Oncol. 2018 Mar 6. doi: 10.1001/jamaoncol.2017.5697 [Epub ahead of print]
  3. Gyawali B, Ando Y. Adjuvant sunitinib for high-risk-resected renal cell carcinoma: a meta-analysis of ASSURE and S-TRAC trials. Ann Oncol. 2017;28(4):898-9. doi: 10.1093/annonc/mdw667
  4. Gyawali B, Sullivan R, Booth CM. Cancer groundshot: going global before going to the moon. Lancet Oncol. 2018;19(3):288-90. doi: 10.1016/S1470-2045(18)30076-7