|
| Drugs | Pharmacogenomic biomarker or variant allele | Response phenotype | Regulatory decision and/or clinical recommendation |
|
| Abacavir | HLA-B*5701 | Hypersensitivity reactions | FDA and EMA warn of increased risk in patients with HLA-B*5701. Genetic screening recommended before starting therapy. Patients tested positive should not receive abacavir. |
| Azathioprine and 6-mercaptopurine | Defective TPMT alleles
(e.g. TMPT*2) | Myelosuppression | Increased risk for myelotoxicity in homozygotes treated with conventional doses. FDA recommends genetic testing prior to treatment. |
| Carbamazepine | HLA-B*1502 | Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) | FDA warns of increased risk for increased risk of SJS and TEN in patients with HLA-B*1502. Patients from high-risk regions (e.g., Southeast Asia) should be screened for HLA-B*1502 before starting carbamazepine. |
| Cetuximab and panitumumab | EGRF, KRAS | Efficacy | With clinical benefit limited to patients with EGRF-positive tumors, both chemotherapeutic drugs are indicated for EGRF-expressing colorectal cancer with wild-type KRAS. They may be ineffective in patients with tumors expressing KRAS mutation. Mandatory testing required. |
| Codeine | Duplicated or amplified CYP2D6 alleles | CNS depression | FDA warning regarding patients who are ultrarapid metabolizers secondary to the CYP2D6*2XN genotype would have much higher morphine concentration, and at increased risk for CNS symptoms related to overdose, even when treated with standard doses. |
| Clopidogrel | Defective CYP2C19 alleles (e.g. CYP2C19*2, CYP2C19*3) | Efficacy | FDA warns of possible reduced effectiveness in CYP2C19 homozygotes. |
| Crizotinib | ALK | Efficacy | Mandatory testing required by the FDA to confirm the presence of lymphoma kinase (ALK) mutation prior to drug use. |
| Gefitinib | EGRF | Efficacy | Approved by EMA for treatment of EGRF-expressing tumors. |
| Imatinib | BCR-ABL translocation | Efficacy | Mandatory testing required by the FDA for confirmation of disease and selection of patients for which the drug is indicated. |
| Irinotecan | UGT1A1*28 | Neutropenia | FDA recommends dosage reduction by one level in homozygotes. |
| Maraviroc | CCR-5 | Efficacy | FDA and EMA approved indication is only for HIV infection with CCR-5-tropic-HIV-1. |
| Trastuzumab | HER2 | Efficacy | FDA and EMA require mandatory testing for HER2-overexpressing cancers prior to treatment. |
| Vemurafenib | BRAF V600E mutation | Efficacy | FDA requires mandatory testing for the mutation prior to drug use. |
| Warfarin | CYP2C9
VKORC1 | Efficacy and toxicity (bleeding) | FDA provides dose recommendations according to CYP2C9 and VKORC1 genotypes. |
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