Bridging drug labels and precision medicine: pharmacogenomic opportunities in recent US-FDA drug approvals.

BACKGROUND

Pharmacogenomics (PGx) information in US-FDA drug labels supports precision prescribing. This study aimed to quantify the proportion of recent US-FDA-approved drug labels containing PGx information, identify additional drugs with potential PGx relevance through mechanistic pathway analysis, and assess the availability of US-FDA-approved companion diagnostic tests.

METHODS

Novel systemic drugs approved by the US-FDA between 1 January 2021 and 31 December 2025 were identified. Drug labels were evaluated using the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling. Drugs without labeled PGx information were assessed for potential PGx relevance through evaluation of metabolic enzymes and transporter pathways using CPIC, DPWG, and PharmGKB. Availability of US-FDA-approved companion diagnostic tests was recorded.

RESULTS

Of the 206 novel drugs included, 85 (41%) contained PGx information, with oncology representing the largest therapeutic area. Mechanistic pathway analysis identified an additional 13 and 39 potential PGx candidate drugs according to CPIC and PharmGKB/DPWG, respectively. The proportion of drugs with PGx labeling remained relatively stable between 2021 and 2024. Overall, 42% labeled PGx drugs had US-FDA-approved companion diagnostic tests.

CONCLUSION

Although PGx information is increasingly incorporated into recent US-FDA drug labels, additional candidate drugs and limited companion diagnostics indicate opportunities to advance precision medicine.