Vonjo: how was the first human dose set?

The public FDA and EMA reviews of Vonjo don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

In cancer patients the start dose should be pharmacologically active yet reasonably safe. A common small-molecule approach is one-tenth of the dose severely toxic to 10% of rodents, or one-sixth of the highest non-severely toxic dose in non-rodents.

NOAEL / key findings: 39-week dog NOAEL 20 mg/kg/day, based on mortality, weight loss and GI toxicity at the high dose (FDA integrated review, p. 118)

Full method, every step sourced →