The importance and utility of post market drug safety monitoring in cancer therapy

Considering the clinical immaturity of targeted agents at their launch, partly due to expedited approvals, the new mechanisms of cell killing and the novel technologies of manufacturing, the postmarketing safety surveillance is a critical feature to secure their use. Pharmacoepidemiologic studies based on electronic health-based data will help to identify emergent and late safety events and to investigate their etiology along with predisposition factors. Work is also needed to elucidate the sex differences in toxicity of targeted therapies and to harmonize withdrawal decisions of drug regulatory agencies for safety reasons.