KSR: What is Project Optimus and why is it important?
PP: Project Optimus is the US FDA’s push to address a longstanding debate in oncology drug development: how we choose dose. Under this initiative, sponsors are now expected to study multiple clinically relevant doses and justify dose selection using the totality of the evidence.
The explicit goal is to identify a dose that optimises efficacy while also accounting for safety and tolerability.
In plain terms, the FDA is saying that finding a dose that works is not enough. It must be a dose that meets patient expectations in terms of both efficacy and safety.
This matters because oncology has relied for decades on a dose-selection model built for cytotoxic chemotherapy.
Based on the assumption that higher exposure leads to better tumour control, the maximum tolerated dose (MTD) became the default.
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