Project Optimus
An FDA programme pushing companies to find the best dose of a cancer drug, not just the highest tolerable one.
Launched by the FDA Oncology Center of Excellence in 2021, Project Optimus requires randomised dose comparison and exposure-response work before pivotal trials, reversing the maximum-tolerated-dose paradigm inherited from chemotherapy. It has changed early-phase design for targeted agents and ADCs (dose-optimisation cohorts, lower approved doses such as sotorasib 240 mg).
Pages like this
not linked directly; found by shared links- TermOcular toxicity (keratopathy, blurred vision)
Shares Therapeutic index (therapeutic window), Dose reduction, interruption and discontinuation, Antibody-drug conjugate (ADC).
- TermFirst-in-human (FIH) trial
Shares Dose-escalation designs (3+3, BOIN, dose-expansion), Maximum tolerated dose (MTD).
- 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, Sotorasib, Small-molecule kinase inhibitors.
- TermCTCAE toxicity grading (grade 3-4 adverse events)
Shares Dose-limiting toxicity (DLT), Dose reduction, interruption and discontinuation.
- 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, Sotorasib.
- TermHyperglycaemia (PI3K/AKT inhibitor class effect)
Shares Therapeutic index (therapeutic window), Dose reduction, interruption and discontinuation.
- TermFebrile neutropenia
Shares Dose-limiting toxicity (DLT), Dose reduction, interruption and discontinuation.
- 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, Sotorasib.