Apply Project Optimus to drugs already on the market
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.
Overview
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.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.
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not linked directly; found by shared links- IdeaRandomise at least two doses in phase 2 before any pivotal trial
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses, Toxicity and quality of life are undervalued.
- IdeaRandomised lower-dose trials for approved drugs with quality of life as the primary endpoint
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses, Toxicity and quality of life are undervalued.
- IdeaExposure-response modelling with a pre-set target exposure before any dose is chosen
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
- IdeaTest one-tenth-dose immunotherapy where the full dose is unaffordable
Shares Project Optimus, Wrong doses, Prices and value.
- IdeaMake pre-approval dose optimisation an ICH standard so it is done once worldwide
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
- IdeaShare vials and round doses to stop throwing away expensive drug
Shares Wrong doses, Prices and value.
- IdeaPayers price drugs on quality-adjusted benefit, so toxicity costs the manufacturer
Shares Prices and value, Toxicity and quality of life are undervalued.
- IdeaScreen every cancer patient for financial toxicity as a vital sign, with navigation
Shares Prices and value, Toxicity and quality of life are undervalued.