The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.

ABSTRACT: The accelerated approval (AA) pathway was established by the United States Food and Drug Administration (FDA) to provide earlier access to therapies for patients with serious medical conditions and unmet medical needs. Since its inception, the AA pathway has been used for novel treatments across different therapeutic areas, but most prominently in oncology, including the immune checkpoint inhibitor class. This review article describes the history of regulatory approvals for pembrolizumab, an immunotherapy agent targeting programmed death receptor-1 (PD-1), and use of the AA pathway and the corresponding regulatory decisions made by the FDA. From its first AA in September 2014 to February 2024, pembrolizumab has used the accelerated pathway for roughly 40% of the approved indications listed

SUBMITTER: Kester R 

PROVIDER: S-EPMC11652590 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature