Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.

ABSTRACT: To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that manufacturers conduct additional studies during the postmarketing period. As a growing proportion of new cancer drugs are approved on the basis of limited evidence of clinical benefit, timely completion of postmarketing requirements is important. We used publicly available regulatory documents to evaluate key characteristics of pivotal studies supporting EMA-approved cancer drugs from 2004-2014 and assessed completion rates of postmarketing data collection requirements after a minimum of 5 years. From 2004-2014, 79% (45/57) of EMA-approved cancer drugs had to fulfill postmarketing requirements. Pivotal trials supporting the approval of cancer drugs wi

SUBMITTER: Cherla A 

PROVIDER: S-EPMC9540185 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature