Some changes in body weight and bod

Some changes in body weight and body weight gain were observed, more predominantly seen in the high dose group (10 mg/kg/day). In terms of gross pathological changes, there were no significant differences between control and treatment groups for male rats. In female rats there were higher incidences of pituitary gland adenomas in the 3 mg/kg/day group, higher than vehicle control but consistent with levels in the water control group. Adrenal glands were also observed to be dark, pale or focused in females treated with 10 mg/kg/day neratinib. Overall it can be concluded that the changes observed between treatment and control population were of limited significance for increased carcinogenic potential. The pituitary and adrenal glands appear to be a target following extended exposure to neratinib. However there is no clear differentiation between treated and control animals to trigger a potential signal for carcinogenicity.