Cherla, Avi; Mossialos, Elias; Salcher-Konrad, Maximilian; Kesselheim, Aaron S; Naci, Huseyin (2022): Post-marketing requirements for cancer drugs approved by the European Medicines Agency, 2004-2014. Clinical Pharmacology & Therapeutics, 112 (4). pp. 846-852.

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Official URL (please open in a new browser tab/window): https://doi.org/10.1002/cpt.2679

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 post-marketing period. As a growing proportion of new cancer drugs are approved on the basis of limited evidence of clinical benefit, timely completion of post-marketing 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 post-marketing data collection requirements after a minimum of 5 years. From 2004-2014, 79% (45/57) of EMA-approved cancer drugs had to fulfill post-marketing requirements. Pivotal trials supporting the approval of cancer drugs with post-marketing requirements were less likely to have randomized designs (41/61, 67% vs 11/11, 100%), include an active comparator (20/61, 33% vs 10/11, 91%), or measure overall survival as the primary study endpoint (18/61, 30% vs 6/11, 55%) compared to pivotal trials for drugs without post-marketing requirements. Among 200 post-marketing requirements, almost half were designed to assess drug safety. After a minimum of 5 years, 60% (121/200) of requirements were completed, 10% (19/200) were ongoing, and 30% (60/200) were delayed. About half (40/75, 53%) of post-marketing requirements for new clinical studies were completed on time. Delays in the completion of post-marketing requirements often did not impact the likelihood of drugs receiving permanent marketing authorization (87%, 39/45) after 5 years. Our findings highlight the need for EMA to better enforce its authority to require timely completion of post-marketing requirements and studies.

Item Type: Article
Subjects: OEBIG > Pharmaoekonomie
Date Deposited: 23 Jun 2022 11:04
Last Modified: 27 Apr 2023 08:50
URI: https://jasmin.goeg.at/id/eprint/2266