Relugolix: Five Reasons Why the US Food and Drug Administration Should Have Exercised Restraint

Kerrington Powell; Michael C Burns; Vinay Prasad

doi:10.1016/j.eururo.2022.08.029

Relugolix: Five Reasons Why the US Food and Drug Administration Should Have Exercised Restraint

Eur Urol. 2023 Feb;83(2):101-102. doi: 10.1016/j.eururo.2022.08.029. Epub 2022 Sep 22.

Authors

Kerrington Powell¹, Michael C Burns², Vinay Prasad³

Affiliations

¹ College of Medicine, Texas A&M Health Science Center, Bryan, TX, USA.
² Department of Hematology-Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
³ Department of Epidemiology and Biostatistics, University of California-San Francisco, San Francisco, CA, USA. Electronic address: vinayak.prasad@ucsf.edu.

PMID: 36153246
DOI: 10.1016/j.eururo.2022.08.029

Abstract

We highlight concerns regarding the approval of relugolix for patients with prostate cancer. These include the unsuitable comparator arm and primary endpoint in the HERO trial, as well as potential selection bias and the poor representativeness of the trial population. Dosing adherence to a daily tablet may also be an issue in comparison to injections at 3-mo intervals. Rigorous postmarketing trials of relugolix assessing clinically meaningful endpoints for these patients are needed.

Publication types

Editorial
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Male
Phenylurea Compounds*
Prostatic Neoplasms* / drug therapy
Pyrimidinones
United States
United States Food and Drug Administration

Substances

relugolix
Phenylurea Compounds
Pyrimidinones