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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.
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.
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.
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.
Shares Wrong doses, Prices and value.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Wrong doses, Prices and value.