Dose selection and tolerability of anticancer agents evaluated by the European Medicines Agency in the period 2015-2020.

ABSTRACT:

Background

Novel anticancer agents are initially evaluated in a palliative setting in phase I studies. The benefit-risk applying the selected dose from these phase I studies can be considered acceptable at time of registration, however, it is unknown if the optimal dose has been selected during drug development.

Methods

The European Medicines Agency (EMA) European Public Assessment Reports (EPARs) overview was used to select anticancer agents evaluated between 2015 and 2020. The dose selection and tolerability data of EMA assessed anticancer agents was analysed to evaluate dose selection.

Results

Sixty EPARs were included for analysis. A dose-response relation was identified in five dossiers (8%). The maximum tolerated dose (MTD) was the selected dose for 15 anticance

SUBMITTER: Maliepaard M 

PROVIDER: S-EPMC8586755 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature