# Apply Project Optimus to drugs already on the market

Source: https://onco.cc/ideas/idea-cost-optimus-legacy-drugs/  
OnCo record `idea-cost-optimus-legacy-drugs` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-10
- 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.
- Proposed test: FDA and NCI co-sponsor randomised dose-comparison trials embedded in cooperative groups, with efficacy, toxicity and cost endpoints.
- Maturity: speculative
- Actor: regulator

## Sources

- FDA guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (August 2024): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases

## Connected records

- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- terms: [Project Optimus](https://onco.cc/terms/project-optimus/)
- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- key papers: [FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high](https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/)

---
JSON: https://onco.cc/api/v1/entities/idea-cost-optimus-legacy-drugs.json