Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.

ABSTRACT:

Importance

The accelerated approval pathway was developed to expedite US Food and Drug Administration (FDA) drug approval for life-threatening conditions based on changes to unvalidated surrogate measures, with conversion to regular approval then based on a required confirmatory trial. However, confirmatory trials may not be completed in a timely fashion.

Objective

To analyze factors associated with time to conversion to regular approval.

Design, setting, and participants

This cohort study of cancer drugs FDA-approved from 1992 to 2022 extracted pivotal and confirmatory trial characteristics, outcomes, safety data, and confirmatory study status at approval from drug labels and published reports. Clinical benefit was assessed using the European Society of Medical Oncol

SUBMITTER: Tibau A 

PROVIDER: S-EPMC11947834 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature