Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'.

ABSTRACT:

Background

The magnitude of clinical benefit of solid cancer drugs can be standardly assessed via the Magnitude of Clinical Benefit Scale (MCBS) developed by the European Society for Medical Oncology (ESMO). We applied two ESMO-MCBS versions to the last 12 years of European cancer drug approval and compared two predefined marketing authorisation timeframes to identify potential score changes over time.

Material and methods

Originator solid cancer drugs and indication extensions that were approved between 1 January 2009 and 31 October 2020 by the European Medicines Agency (EMA) were included in our analyses. To evaluate the clinical benefit of these cancer indications, the original ESMO-MCBS (v 1.1) and a locally adapted ESMO-MCBS version were applied to the study sample. Thu

SUBMITTER: Grossmann N 

PROVIDER: S-EPMC8182388 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature