Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs

Purpose: The aim of this study was to compare guidance for genetic testing in US Food and Drug Administration (FDA)-approved drug labels in oncology to those of drugs for other therapeutic areas. Methods: We reviewed labels of all the FDA-approved drugs with labels containing pharmacogenomic information. We assessed whether genetic testing was required or recommended before prescription and, if not, the reason for pharmacogenomic labeling. Results: We included 140 drugs corresponding to 158 drug-biomarker pairs. Overall, 46 (29%) of 158 pairs stated a requirement or recommendation for genetic biomarker testing in the label. This proportion was higher in oncology than in other areas (62 vs. 12%; P < 0.001). For the 112 drug-biomarker pairs (including 20 in oncology) without recommendation or requirement for genetic testing, the main reasons for pharmacogenomic labeling were change in pharmacologic end points (32%) and higher risk of toxicity (30%). For 11 (10%) pairs (including 1 in oncology), a genetic biomarker was mentioned only to inform that it was not relevant. In oncology, the main reasons for pharmacogenomic labeling were higher risk of toxicity (55%) and definition of the mechanism of action (25%). Conclusion: Inclusion of biomarkers in drug labels does not always correspond to required or recommended genetic testing, especially outside oncology. Genet Med advance