Next-in-class drugs should, in theory, improve the therapeutic ratio, lower costs through market competition, or both. A look-back at FDA approvals for oncologic drugs between 2009-2020 suggests otherwise, as a minority of approvals rested on any within-class randomized trial. The authors–including the FDA’s own Director for the Center for Biologics Evaluation and Research–suggest “future regulatory frameworks should consider mandating head-to-head trials against existing in-class agents whenever feasible.” | Olivier, JAMA Intern Med 2025
