Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval by the US FDA but failed to improve the primary outcome in post-approval trials and to evaluate the extent to which negative post-approval trials changed the recommendations in treatment guidelines.
18 indications for 10 cancer drugs that received accelerated approval but failed to improve the primary outcome in post-approval trials were identified.
