Perjeta: how was the first human dose set?

The public FDA and EMA reviews of Perjeta 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: No NOAEL in 26-week study: severe diarrhoea and increased urea nitrogen at all dose levels (EMA assessment report, p. 38)

Full method, every step sourced →