Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review.

ABSTRACT:

Importance

For patients with cancer treated with palliative intent, quality of life (QOL) is a critical aspect of treatment decision-making, alongside survival. However, regulatory approval can be based solely on survival measures or antitumor activities, without QOL evidence.

Objective

To investigate whether recently approved oncology therapies demonstrate clinically meaningful improvements in QOL.

Evidence review

This systematic review study identified oncology drug indications approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) from January 2006 to December 2017 and supporting clinical trials (QOL publications identified to October 2019). Indications were evaluated for the presence of published QOL evidence; QOL benefits accord

SUBMITTER: Arciero V 

PROVIDER: S-EPMC7879236 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature