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A few pointers

FIH Starting Dose for an Oncology NME

Predominantly drug developers of small molecules use a general approach to set a starting dose at 1/10 the Severely Toxic Dose in 10% (i.e. 1 out of 10 rats, STD 10) of the animals in rodents. However, if the non-rodent is the most sensitive species then 1/6 the Highest Non- Severely Toxic Dose (HNSTD) should be considered an appropriate starting dose for FIH phase 1 study. The HNSTD is defined as the highest dose level that does not produce evidence of lethal/life-threatening toxicities or irreversible findings.

Oncology Drug Development
Based on the historical and regulatory precedence in the oncology drug development, it is unlikely to get an initial/or a first approval in 1st line setting for a new single agent that belongs to a class of drugs whose MOA is yet to be proven/validated as an effective anticancer agent. Usually, an initial Approval is first obtained in a pre-treated population (i.e. 2nd or 3rd line etc)