Gastrointestinal toxicities are a c

Gastrointestinal toxicities are a class effect of EGFR TKIs, but the very high incidence of diarrhoea is a particular safety concern of neratinib treatment. However, this side effect is reversible on discontinuation. Data indicate a limited effect of loperamide, and a possible beneficial effect of colestipol. However, the apparent effect of combining loperamide with colestipol could considerably reduce the diarrhoea problem. The applicant has commited to further investigate optimal diarrhoea management post approval (see RMP). In the absence of other major concerns the safety profile is considered acceptable.