FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit

Nature Reviews Clinical Oncology, Published online: 21 February 2024; doi:10.1038/s41571-024-00871-5In 2023, the US FDA approved several new cancer drugs and biologic agents, including seven small-molecule inhibitors, four bispecific T cell engagers, two anti-PD-1 antibodies and one cell therapy product. Regulatory focus areas included analyses of biomarker-positive subgroups that drive efficacy, equipoise in randomized controlled trials and a new authority to require confirmatory trials be underway before accelerated approval.
Source: Nature Reviews Clinical Oncology - Category: Cancer & Oncology Authors: Source Type: research