TABLE 1.

FDA-mandated product labeling: Genetic biomarkers and their clinical context

C-KIT (cytokine receptor) Imatinib mesylate (Gleevec) is indicated for the treatment of patients with Kit (CD117)-positive unresectable tumors or metastatic malignant gastrointestinal stromal tumors (GIST).

CCR5 (C-C chemokine receptor type 5) Maraviroc (Selzentry) is indicated for treatment-experienced adult patients infected with CCR5-tropic HIV-1 infection.

Chromosome 5q Lenalidomide (Revlimid) is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-risk myelodysplastic syndromes associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

Familial hypercholesterolemia Atorvastatin (Lipitor) dosage adjustment is necessary for children who have homozygous or heterozygous familial hypercholesterolemia.

G6PD (glucose-6-phosphate dehydrogenase) Testing for G6PD deficiency is recommended in high-risk populations before starting treatment with rasburicase (Elitek).

HER2/neu (human epidermal growth factor receptor 2) HER2 testing is recommended before starting treatment with trastuzumab (Herceptin).

HLA-B*1502 (major histocompatibility complex, class I, B) HLA-B testing is recommended in high-risk populations before starting treatment with carbamazepine (Tegretol, Equetro).

HLA-B*5701 (major histocompatibility complex, class I, B) HLA-B testing is recommended before starting treatment with abacavir (Ziagen).

Philadelphia (Ph1) chromosome Dasatinib (Sprycel) is indicated for treatment of adults with Philadelphia-chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

TPMT (thiopurine methyltransferase) TPMT testing is recommended before starting treatment with azathioprine (Imuran).

ADAPTED FROM US FOOD AND DRUG ADMINISTRATION (FDA). TABLE OF PHARMACOGENOMIC BIOMARKERS IN DRUG LABELS. WWW.FDA.GOV/DRUGS/SCIENCERESEARCH/RESEARCHAREAS/PHARMACOGENETICS/UCM083378.HTM. ACCESSED 2/3/2011.