Bridging the gap: FDA diversity-related postmarketing requirements.

Abstract

e13608 Background: Historically, pre-market clinical trials have lacked enrollment of racial and ethnic minority patients that represent the population intended to be treated with the approved drug in the US. The Food and Drug Administration (FDA) has several programs and initiatives designed to enhance diversity in oncology clinical trials, such as the Oncology Center of Excellence’s (OCE) Project Equity, FDA Guidance documents, and submission of Diversity Plans from industry. Under the code of federal regulations and/or statute, the FDA can issue post-marketing requirements (PMR) to fulfill accelerated approval requirements for confirmatory studies; for assessing safety signals; or for conducting dedicated studies in pediatric patients. FDA may also issue post-marketing commitments (PMC) to generate additional clinical evidence. PMRs and PMCs have been used to obtain additional information on under-represented populations. The objectives of this analysis were to identify oncology PMRs/PMCs issued with a specific focus on racial and ethnic minority populations and examine the trend over the 10-year period. Methods: We searched FDA’s publicly available database of PMR/PMCs, inclusive of drugs and biologic products, and internal agency databases for PMR/PMCs issued between 2012-2022. The PMR/PMC search was further narrowed down by keywords to capture all PMRs/PMCs relevant to races and ethnicity. The PMRs/PMCs were then manually reviewed for duplication and applicability to malignant indications. Results: In a 10-year period, 34 PMR/PMCs focused on race and ethnicity were issued across 461 oncology approvals (initial marketing approvals = 164, new indications = 297). Twenty-two were issued with the initial marketing approval and 12 with supplemental efficacy approvals. All PMR/PMCs were issued in the last 3 years (2019-2022). PMCs accounted for 55.9% (n = 19) and PMRs 44.1% (n = 15). Nine of the 15 PMRs requesting additional information on underrepresented populations were included with the accelerated approval PMRs. Six of the 34 PMR/PMCs were issued to obtain additional PK or dosing information in the underrepresented population. The most common PMR/PMC indications issued were lymphoma (n = 13, 38.2%), multiple myeloma (n = 8, 23.5%), and non-small cell lung cancer (n = 4, 11.8%). Although PMR/PMCs that mentioned a specific race were limited, African American/Black (n = 8) and Asian (n = 1) were occasionally identified. All studies identified in this analysis are ongoing except for one, for which the product was withdrawn. Conclusions: Our analysis highlights the trend and increased emphasis on race and ethnicity in post approval oncology studies. While progress has been made to promote studies that are representative of the US population through these PMRs/PMCs, diversity plans, and FDA guidance over the course of the past 10 years, more efforts are needed to better enhance diversity in clinical trials moving forward.