The drugs and diagnostic tests listed in the table below are the leading edge of a wave of new personalized medicine products likely to emerge over the next several years. They are the dividend from government and pharmaceutical research company investment into biomedical and human genome research.
Selected Personalized Medicine Drugs, Treatments, and Diagnostics*
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Therapy
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Biomarker/Test
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Indication
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Anti-retroviral drugs
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TruGene®-HIV 1 Genotyping Kit
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Guides selection of therapy based on genetic variations that make the HIV virus resistant to some anti-retroviral drugs.
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Cancer treatment regimens
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Oncotype DX™ 21-gene assay
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Quantifies the expression of 21 genes linked to the likelihood of breast cancer recurrence in women, and the magnitude of benefit from certain types of chemotherapy and hormonal therapy.
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Camptosar® (irinotecan)
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UGT1A1
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Colon cancer: "Variations in the UGT1A1 gene can influence a patient's ability to break down irinotecan, which can lead to increased blood levels of the drug and a higher risk of side effects." 1
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Drugs metabolized by cytochrome P450
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Amplichip® CYP2D6/
CYP2C19
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FDA classification 21 CFR 862.3360: "This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information." 2
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Gleevec® (imatinib mesylate)
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BCR-ABL |
Chronic myelogenous leukemia (CML): "Gleevec (imatinib mesylate) is indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in
chronic phase after failure of interferon-alpha therapy." 3
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|
Gleevec® (imatinib mesylate)
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c-KIT
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Gastrointestinal stromal tumor (GIST): "Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)." 3
|
| Herceptin®(trastuzumab) |
HER-2/neu receptor |
Breast cancer: "...for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease." 4 |
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Immunosuppressive drugs
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AlloMap® gene profile
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Monitors patient's immune response to heart transplant to guide immunosuppressive therapy.
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Pharmaceutical and surgical prevention options and surveillance
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BRCA 1,2
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Guides surveillance/preventive treatment based on susceptibility risk for breast and ovarian cancer.
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Pharmaceutical and lifestyle prevention options
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Familion® 5-gene profile
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Guides prevention and drug selection for patients with inherited cardiac channelopathies such as Long QT Syndrome (LQTS), which can lead to cardiac rhythm abnormalities.
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Pharmaceutical and surgical treatment options and surveillance
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p16/CDKN2A
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Guides surveillance/preventive treatment based on susceptibility risk for melanoma.
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Purinethol® (mercaptopurine)
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TPMT
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Guides adjustment of dose in treatment of acute lymphoblastic leukemia: "Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe Purinethol toxicity from conventional doses..." 5
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Tamoxifen
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Estrogen receptor
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"The estrogen and progesterone receptor values [in breast cancer patients] may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial." 6
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Entries in which diagnostic tests received FDA approval, or drugs that have a reference to pharmacogenomic selection in their label, are shown in blue. All other entries include marketed tests conducted in CLIA-certified clinical reference laboratories.
BCR-ABL = breakpoint cluster region - Abelson
BRCA 1,2 = breast cancer susceptibility gene 1 or 2
c-KIT = tyrosine kinase receptor
CYP = cytochrome P450 enzyme
HER2 = human epidermal growth factor receptor 2
TPMT = thiopurine S-methyltransferase
UGT1A1 = UDP-glucuronosyltransferase 1A1
*These products represent a selection of recognized interventions across the spectrum of personalized medicine technologies. The list is based on materials developed by the Personalized Medicine Coalition.
Visit the site for regular updates as new information becomes available. If you have suggestions for additional content in this area, please contact us.
1 U.S. Food and Drug Administration, FDA Clears Genetic Test That Advances Personalized Medicine Test Helps Determine Safety of Drug Therapy 22 August 2005,
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01220.html (accessed 15 August 2006)
2 U.S. Food and Drug Administration, FDA classification 21 CFR 862.3360 1 April 2005,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=862.3360 (accessed 15 August 2006)
3 U.S. Food and Drug Administration, FDA Oncology Tools Approval Summary for imatinib mesylate for Accel. Approv,
http://www.accessdata.fda.gov/scripts/cder/onctools/summary.cfm?ID=326 (accessed 15 August 2006)
4 U.S. Food and Drug Administration, FDA Oncology Tools Product Label Details in Conventional Order for trastuzumab,
http://www.accessdata.fda.gov/scripts/cder/onctools/labels.cfm?GN=Trastuzumab (accessed 15 August 2006)
5 U.S. Food and Drug Administration, Purinethol® drug label,
http://www.fda.gov/Medwatch/SAFETY/2004/jul_PI/Purinethol_PI.pdf (accessed 15 August 2006)
6 U.S. Food and Drug Administration, FDA Oncology Tools Product Label Details in Conventional Order for tamoxifen,
http://www.accessdata.fda.gov/scripts/cder/onctools/labels.cfm?GN=tamoxifen (accessed 15 August 2006)
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