TABLE 2.
FDA CDER: Abbreviated Table of Pharmacogenomic Biomarkers in Drug Labeling
For each of the 517 gene-drug pairs in the FDA (2022) table, the drug labels include clinically actionable pharmacogenomics information. Some of these combinations are mandatory: the test must be taken before the drug can be dispensed (or reimbursed by the insurer); however, the FDA table does not specify how the biomarkers are to be applied. Drugs are marked with stars to indicate how stringent test requirements are; absence of a * marker indicates that testing may be considered on case-by-case basis. (https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling).
| Drug Link in Drugs@FDA |
Therapeutic Area | Biomarker | Label Sections with Pharmacogenomic Information |
|---|---|---|---|
| Abacavir** | Antivirals | HLA-B*5701 | Boxed Warning, Contraindications Warnings and Precautions Patient Counseling |
| Atezoliozumab* | Oncology | PD-L1, gene signature, GFR, ALK, BRAF | Indications and Usage, Dosage and Administration, Adverse Reactions |
| Carbamazepine** | Neurology | HLA-B*1502 | Boxed Warning, Warnings, Precautions |
| Cetuximab* | Oncology | EGFR KRAS |
Indications and Usage Warnings and Precautions Indications and Usage |
| Clopidogrel | Cardiology | CYP2C19 | Boxed Warning, Warnings and Precautions |
| Clozapine | Psychiatry | CYP2D6 | Dosage and Administration, Use in Specific Populations, Clinical Pharmacology |
| Codeine | Anesthesiology | CYP2D6 | Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information |
| Dasatinib* | Oncology | Ph Chromosome | Indications and Usage |
| Doxepin | Psychiatry | CYP2D6 | Precautions |
| Elosulfase* | Inborn Errors of Metabolism | GALNS | Indications and Usage, Warnings and Precautions, Use in Specific Populations |
| Imatinib* | Oncology | C-KIT, PH Chrom., PDGFR, FIP1L1-PDGFRa | Indications and Usage, Adverse Reactions, Use in Specific Populations |
| Ivacaftor* | Pulmonary | CFTR | Indications and Usage, Adverse Reactions, Use in Specific Populations |
| Maraviroc* | Antivirals | CCR5 | Warnings and Precautions |
| Nitrofurantoin | Infectious Diseases | G6PD | Warnings, Adverse Reactions |
| Tamoxifen | Oncology | ESR, F5, F2, CYP2D6 | Indications and Usage |
| Thioguanine | Oncology | TPMT, NUDT15 | Dosage and Administration, Warnings, Precautions, Clinical Pharmacology |
| Trastuzumab**,** | Oncology | ERB2 (HER2) | Indications and Usage, Dosage and Administration |
CDER, Center for Drug Evaluation and Research.
*biomarker testing required; ** biomarker testing strongly advised; ***Herceptin.