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Many cancer drugs are approved at the highest dose patients could stand, not the best dose. Run trials that test lower doses on approved drugs and measure how patients feel.
Maximum tolerated dose remains the default for oral targeted agents and many antibody-drug conjugates; discontinuation for toxicity is common (abemaciclib, lenvatinib, cabozantinib, sotorasib). FDA Project Optimus addresses new drugs, not the existing catalogue. The proposal is a funded programme of post-marketing randomised non-inferiority trials of reduced or adaptive doses with patient-reported tolerability as primary and progression-free survival as a non-inferiority secondary, with regulators committed to label updates.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Sotorasib, 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, Sotorasib, Wrong doses.
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 Abemaciclib, 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.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Wrong doses, Toxicity and quality of life are undervalued.