Many oral anticancer agents are recommended to be given either at least 1 h before or 2 h after a meal, according to the prescribing information. However, the effect of dosage timing of an oral anticancer agent with reference to food intake on anticancer treatment remains unclear. As shown by the literature survey and labeling analysis for oral anticancer drugs approved by the US Food and Drug Administration from 2010 to 2016, labeling information regarding dosage timing for several anticancer drugs appeared not be optimum, leading to suboptimal bioavailability and plasma drug concentrations. This supports a call to regularly recalibrate the labeling information for dosage timing of oral anticancer medications to minimize the risks of compromised efficacy or unintended toxicities.
Conflicting food recommendations between regulatory authorities could have a large impact on anticancer treatment and patients' quality of life, leading to suboptimal clinical outcomes. As the most important source of dosing instructions, the labeling information should be regularly recalibrated to provide consistent and informative instructions for drug intake in relation to meals, minimizing unintended interactions with meals and improving patient compliance and adherence. Further efforts on harmonizing food recommendations between regulatory agencies are highly warranted to assure optimal outcomes for individual patients. Moreover, meal-drug interaction studies should be conducted as early as possible to inform the dosing schedules of the subsequent phase 2 and phase 3 trials, thereby facilitating regulatory decision-making in regard to the method of drug administration.
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