Relugolix: Five Reasons Why the US Food and Drug Administration Should Have Exercised Restraint.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 36153246.
- Also identified by DOI 10.1016/j.eururo.2022.08.029.
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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.
Medical subject headings
- Phenylurea Compounds
- Prostatic Neoplasms