{"entity":{"id":"idea-cost-optimus-legacy-drugs","kind":"idea","name":"Apply Project Optimus to drugs already on the market","aka":[],"tldr":"The FDA now requires new cancer drugs to prove their dose is the right one rather than the highest tolerated; asking the same question of the twenty best-selling approved drugs could cut doses, side effects and cost at once.","summary":"The FDA's Project Optimus and its 2024 final guidance require sponsors to compare doses before approval. Most approved targeted drugs and antibodies were never dose-optimised: a maximum tolerated dose from phase 1 became the label. A post-marketing programme, with FDA authority to require dose-comparison studies as a condition of continued approval or through the accelerated-approval confirmatory pathway, would revisit the doses of high-spend drugs. Lower or less frequent doses save money directly and reduce dose reductions and discontinuations that waste drug.","asOf":"2026-09-10","links":[{"label":"FDA guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (August 2024)","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["fda-oce","nci"],"pathways":[],"terms":["project-optimus"],"trials":[],"people":[],"bottlenecks":["b-dose-optimisation","b-drug-pricing","b-toxicity-qol"],"keyPapers":["paper-drug-dosing-conundrum-nejm-2021"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Post-marketing dose-optimisation studies of ten high-spend oncology drugs will find at least half can be given at a lower dose or longer interval with equal efficacy, saving more than 20% of spend on those drugs.","rationale":"Every time it has been tested (abiraterone, extended-interval pembrolizumab, six-month trastuzumab) a lower or shorter regimen has held up.","test":"FDA and NCI co-sponsor randomised dose-comparison trials embedded in cooperative groups, with efficacy, toxicity and cost endpoints.","maturity":"speculative","actor":"regulator","cost":"medium","horizonYears":4},"route":"/ideas/idea-cost-optimus-legacy-drugs/","neighbours":{"institution":[{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"},{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"term":[{"id":"project-optimus","kind":"term","name":"Project Optimus","route":"/terms/project-optimus/"}],"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}],"paper":[{"id":"paper-drug-dosing-conundrum-nejm-2021","kind":"paper","name":"FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high","route":"/key-papers/paper-drug-dosing-conundrum-nejm-2021/"}]}}