FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use
Source: Regulatory News, July 2022
Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open.
“The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of the section of thoracic surgery in the department of surgery at Yale School of Medicine in New Haven, CT, and colleagues wrote in their study. “The clinical trials that defined the safety and efficacy of these innovative treatments were accruing patients during this period and were likely a major route for patients in the preapproval era to access immunotherapy. As a result, disparities in the preapproval era likely reflect a lack of representativeness in the immunotherapy clinical trials.”
While immunotherapy use increased post-approval and this led to some narrowing of disparities, some persisted and new disparities emerged, the authors noted, “Suggesting that FDA approval alone does not ensure the optimal administration of novel treatments in the US.”