The Evolution of Non-Small Cell Lung Cancer Drug Product Market Approval Review Comments

Abstract

The number of available non-small cell lung cancer (NSCLC) treatment options has increased considerably over the past twenty years to address an urgent unmet medical need. As more drug and biologic development programs are executed to evaluate potential therapies, standards begin to develop for the design and conduct of clinical trials. Analyzing Food and Drug Administration (FDA) market application comments may allow sponsors of NSCLC products to adapt their programs to align with evolving standards, justify deviations, and quickly bring patients meaningful therapeutic options. This study examines FDA comments within NSCLC product summaries based on approval documents and market approval letters to evaluate how these comments have changed over time. A database was created for NSCLC-indicated drug and biologic products approved between 2002 and 2022. Information such as whether NSCLC was the initial approved indication for the product, acquiring expedited programs and orphan designation, and requirement for an FDA Advisory Committee meeting and risk evaluation and mitigation strategy was collected. FDA comments regarding post-market commitments, efficacy, and safety-critical to the product review were assessed. The comments were qualitatively coded into pre-specified categories and then quantitatively analyzed using descriptive statistics. Results highlighted that most approved NSCLC products utilized one or more expedited programs. Due to seeking FDA approval early in the development program, most products had post-approval commitments; efficacy comments reflected limitations inherent in early phase studies, and safety needed to be better defined in some cases. The growing number of innovative products for NSCLC reaching the market through expedited programs has not meaningfully shifted the FDA's efficacy and safety comments; however, a gradual increase in post-approval commitments has been observed since 2019.