{"entity":{"id":"idea-tr1-weight-based-vs-flat-dosing-trials","kind":"idea","name":"Test flat versus weight-based dosing of antibodies, and use dose banding to cut waste","aka":[],"tldr":"Monoclonal antibodies and ADCs have moved from weight-based to flat dosing on modelling alone, which is convenient but gives lighter patients relatively more drug. Randomised or pharmacokinetic comparisons, plus rounding doses to vial sizes where exposure is equivalent, could keep effectiveness while cutting cost and waste.","summary":"Randomised or PK-bridging comparisons of flat versus weight-based (or weight-banded) dosing for monoclonal antibodies and ADCs where flat dosing was adopted on modelling alone; pharmacy dose-banding and vial sharing implemented as policy where exposure equivalence is shown. Payers fund the trials; savings are large because these agents dominate oncology drug spend.","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":[],"sections":[],"technologies":["monoclonal-antibody","adc"],"targets":[],"drugs":["pembrolizumab","trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":["ild"],"trials":[],"people":[],"bottlenecks":["b-dose-optimisation","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Weight-based or banded dosing will be non-inferior to flat dosing for efficacy in most agents studied while reducing drug consumption by 10-25 percent in lighter patients and reducing toxicity for ADCs where exposure drives adverse events.","rationale":"Flat dosing of checkpoint inhibitors was justified by PK modelling, not by outcome trials; for ADCs, exposure-related toxicities (neuropathy, interstitial lung disease, ocular events) argue for tighter exposure control.","test":"Two randomised PK-and-outcome trials, one checkpoint inhibitor and one ADC, comparing flat with weight-banded dosing, with tolerability and cost as key secondaries.","maturity":"early-clinical","actor":"payer","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr1-weight-based-vs-flat-dosing-trials/","neighbours":{"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"term":[{"id":"ild","kind":"term","name":"Interstitial lung disease (ILD) / pneumonitis","route":"/terms/ild/"}],"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}]}}