Increasing the study of novel anticancer therapies in adolescents: Facilitating adolescent inclusion in adult research.

Abstract

e13654 Background: Adolescent cancer patients are disproportionately excluded from clinical trials due to trial designs with lower age limits set to the legal age of majority. This has led to a persistent time lag between adult and pediatric approval of new medicines. Publication of new US regulatory guidance encourages inclusion of adolescents in disease- and/or target-appropriate adult trials to facilitate earlier adolescent access to effective therapies. To understand impacts of this and other initiatives fostering adolescent inclusion, a review of recent cancer drug approvals was performed by the ACCELERATE Fostering Age Inclusive Research (FAIR) group. FAIR is an international research collaborative whose aim is to reduce adolescent inequities in access to novel anticancer therapies. Methods: A comprehensive analysis of new oncology drug approvals in Europe (EMA) and the US (FDA) will be conducted. EMA and FDA databases will be interrogated to identify all novel anticancer drug approvals and new use approvals (innovator and generic or biosimilar) between 2018 and 2022. Specific sections of drug labels (Indications and Usage, Dosing and Administration, Use in Specific Populations, Clinical Pharmacology, Clinical studies) will be evaluated. The study team will assess: inclusiveness of the Indication for Use statement; applicability of the approved indication to an adolescent cohort. This analysis will be conducted in sequence: phase 1 analyzes the EMA approvals, phase 2 analyzes the FDA approvals, followed by a comparative analysis across the regions. Phase 1 data are presented using descriptive statistics. Results:. Conclusions: This research evaluating new European drug approvals shows a limited number of anticancer therapies have been adequately studied or approved for adolescent use, even when the approved indication is relevant to adolescents. Recent regulatory guidance to promote the inclusion of adolescents in adult oncology drug trials has not yet led to an increase in adolescent labelling. Increasing awareness of medical oncologists and study sponsors may facilitate cultural mindset change, leading to expansion of eligibility criterion to adolescents and shortening the time lag of adolescent access to novel anticancer therapies. [Table: see text]