Pharmacovigilance and Risk Management Strategies Conference

The introduction of immuno-oncology (IO) agents (e.g., checkpoint inhibitors) into the clinic has led to huge improvements in the treatment of solid tumors. With these benefits come significant concerns related to immune-mediated organ toxicity which can be severe or fatal and requiring prompt recognition and treatment. An overview of the underlying biology of checkpoint inhibitors will be presented, along with how this translates into safety concerns and how these risks are monitored, assessed, and managed from an industry perspective. This will be followed by a discussion of the challenges facing regulatory agencies in assessing the benefit-risk balance of these agents, how this is evolving as the experience with these agents has increased in the post-approval setting, broader prescriber base and different tumor types, and how this translates into ensuring a positive benefit-risk through continued safety surveillance and risk mitigation measures.