US Food and Drug Administration (FDA) approval of immunotherapies does not eliminate disparities in use, according to research published in JAMA Network Open.
Researchers evaluated sociodemographic and socioeconomic disparities in immunotherapy use among patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma.
Some disparities that existed before FDA approval persisted after approval, and some new disparities emerged after FDA approval.
“Although FDA approval was associated with a significant increase in the use of immunotherapy, gaps persisted, suggesting that FDA approval may not eliminate disparities in the use of novel therapies,” the researchers wrote.
The researchers conducted this study using data from the National Cancer Database. The study included 402,689 patients who were 20 years of age or older and were diagnosed with stage IV NSCLC (n=347,233), RCC (n=43,714), or melanoma (n=11,742) from 2007 to 2018.
Of the included patients, 93.3% were non-Hispanic, 83.4% were White, 11.8% were Black, 3.9% were Hispanic, and 4.1% were other races.
Prior to FDA approval, 3.2% of patients with NSCLC, 4.8% with RCC, and 8.6% with melanoma received immunotherapy. These numbers all increased after approval, to 15.6% for NSCLC, 19.7% for RCC, and 19.3% for melanoma.
Disparities Before Approval
The researchers found that, prior to FDA approval, sociodemographic and socioeconomic characteristics were associated with variable immunotherapy administration by tumor type.
For example, among patients with NSCLC, Black individuals were less likely to receive immunotherapy than White individuals (odds ratio [OR], 0.78; 95% CI, 0.71-0.85; P <.001). However, race was not associated with receipt of immunotherapy for patients with RCC or melanoma.
Hispanic ethnicity was associated with a significantly lower likelihood of receiving immunotherapy for NSCLC (OR, 0.79; 95% CI, 0.67-0.92; P=.003) and melanoma (OR, 0.28; 95% CI, 0.10-0.76; P=.01) but not RCC (OR, 0.79; 95% CI, 0.61-1.02; P =.07).
Among patients with RCC, those without insurance were less likely to receive immunotherapy than those with private insurance (OR, 0.31; 95% CI, 0.20-0.48; P <.001). For all 3 tumors types, patients with Medicare were less likely to receive immunotherapy, compared with patients who had private insurance.
Disparities After Approval
After FDA approval, some of the previously observed disparities were eliminated, but some only narrowed. For example, Hispanic ethnicity was no longer associated with receipt of immunotherapy among patients with melanoma (OR, 1.08; 95% CI, 0.70-1.66; P =.74).
Black patients with NSCLC were still less likely to receive immunotherapy, but the disparity narrowed (OR, 0.87; 95% CI, 0.83-0.91; P <.001). The same pattern was observed for uninsured patients with RCC (OR, 0.60; 95% CI, 0.48-0.75; P <.001).
The researchers noted that other gaps appeared to widen, and new gaps emerged. For example, among patients with RCC, Black race was associated with a lower likelihood of receiving immunotherapy (OR, 0.82; 95% CI, 0.72-0.93; P =.003), as was Hispanic ethnicity (OR, 0.81; 95% CI, 0.70-0.93; P =.003).
According to the researchers, these results suggest that “FDA approval alone does not ensure the optimal administration of novel treatments in the US.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Ermer T, Canavan ME, Maduka RC, et al. Association between Food and Drug Administration approval and disparities in immunotherapy use among patients with cancer in the US. JAMA Netw Open. Published online June 30, 2022. doi:10.1001/jamanetworkopen.2022.19535