{"entity":{"id":"idea-tr1-organ-impairment-pk-before-approval","kind":"idea","name":"Kidney and liver impairment dosing studies completed before approval, not years after","aka":[],"tldr":"Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.","summary":"Regulators require dedicated or population-PK-based organ impairment dosing recommendations (mild, moderate and, where feasible, severe renal and hepatic impairment) as part of the initial marketing application for oncology drugs, rather than as post-marketing commitments, using sparse PK from broadened-eligibility trials and small dedicated cohorts. Ties to relaxing organ-function eligibility criteria.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Wrong doses): FDA Oncology Center of Excellence, Project Optimus","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus"}],"tags":[],"related":[],"cancers":["multiple-myeloma","rcc","hcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-dose-optimisation","b-aging-comorbidity","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Drugs approved with organ-impairment dosing will show lower toxicity-related hospitalisation among patients with impairment in real-world data than drugs approved without, and post-marketing commitments for these studies will fall.","rationale":"Organ impairment is common in cancer patients and clinicians either extrapolate or withhold drugs; post-marketing studies are frequently delayed or never completed.","test":"Audit completion times of organ-impairment post-marketing commitments for the last decade of oncology approvals; then require them pre-approval for three years and compare real-world outcomes in impaired patients.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-organ-impairment-pk-before-approval/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}]}}