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

Abstract

Introduction: Most of the new agents in cancer therapy (referred to as targeted therapies in the paper) come to the market with limited and preliminary data concerning activity and tolerance. Although better tolerated than classical chemotherapy, safety issues of targeted agents must not be underestimated.

Areas covered: The aim of this mini review is to present some pharmacological specifities of targeted anticancer agents and to examine tolerance challenges observed after approval through some examples. References were identified through searches of PubMed for articles published up to March 2025 using the term postmarketing safety AND anticancer agent. Relevant articles were also searched for in high impact journals and specialty journals.

Expert opinion: 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.