FDA approvals in 2024: new options for patients across cancer types and therapeutic classes

Abstract

In 2024, the US FDA approved several new agents for the treatment of patients with cancer, including small-molecule inhibitors, immune-checkpoint inhibitors, bispecific antibodies, antibody–drug conjugates and cell and gene therapy products. Areas of regulatory focus included the accelerated approval programme and diligent completion of post-marketing trials, convening of Oncologic Drugs Advisory Committee meetings to ensure transparent discussions of complex regulatory issues, and continuation of robust, meaningful engagement with the oncology community to foster efficient drug development.