Inluriyo: genotox, carcinogenicity and repro: done or skipped?

“Imlunestrant was not mutagenic in the Ames bacterial reverse mutation assay. Imlunestrant produced chromosomal damage in the in vitro micronucleus assay but did not cause chromosomal damage or DNA strand breaks in vivo when tested up to 2000 mg/kg in the rat comet and bone marrow micronucleus assays.”

“Carcinogenicity studies have not been conducted to support the advanced cancer indication for imlunestrant but are ongoing to support other indications.”

“resulted in embryo-fetal mortality at ≥ 0.3 mg/kg and structural abnormalities at ≥ 3 mg/kg at maternal exposures that were below the human AUC0-24 at the recommended dose.”

“Imlunestrant had no effect on the cardiovascular, central nervous, and respiratory systems of monkeys in 4-week or 3-month toxicology repeat-dose toxicology studies.”