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The Personalized Medicine Product Portfolio
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.
This list is not intended to be comprehensive but reflects commonly used or available products as of March 2009. Some products, for which the FDA recommends or requires pharmacogenomic testing or which have pharmacogenomic information in their label, are listed at the FDA's Web site. Other listed products that are novel, and/or that address large populations, have been identified via Web sites and public announcements.
| Therapeutic product label contains pharmacogenomic information as: | |
|---|---|
| Information only | |
| Recommended | |
| Required | |
Selected Personalized Medicine Drugs, Treatments, and Diagnostics as of March 2009
| Therapy | Biomarker/Test | Indication |
|---|---|---|
| Herceptin® (trastuzumab) Tykerb® (lapatinib) | 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." |
| Pharmaceutical and surgical prevention options and surveillance | BRCA 1,2 | Breast cancer: Guides surveillance and preventive treatment based on susceptibility risk for breast and ovarian cancer. |
| Tamoxifen | Aviara Breast Cancer IndexSM (HOXB13, IL17BR) | Breast cancer: Calculates a combined risk analysis for recurrence after tamoxifen treatment for ER-positive, node-negative breast cancer. |
| Chemotherapy | Mammostrat® | Breast cancer: Prognostic immunohistochemistry (IHC) test used for postmenopausal, node negative, estrogen receptor expressing breast cancer patients who will receive hormonal therapy and are considering adjuvant chemotherapy. |
| Chemotherapy | MammaPrint® | Breast cancer: Assesses risk of distant metastasis in a 70 gene expression profile. |
| Coumadin® (warfarin) | CYP2C9 | Cardiovascular disease: "an increased bleeding risk for patients carrying either the CYP2C9*2 or CYP2C9*3 alleles." |
| Coumadin® (warfarin) | VKORC1 | Cardiovascular disease: "Certain single nucleotide polymorphisms in the VKORC1 gene (especially the -1639G>A allele) have been associated with lower dose requirements for warfarin." |
| Coumadin® (warfarin) | PGx Predict™: Warfarin | Cardiovascular disease: Determines CYP2C9 and VKORC1 genotypes to predict likelihood of adverse events with warfarin therapy. |
| Coumadin® (warfarin) | Protein C deficiencies | Cardiovascular disease: Hereditary or acquired deficiencies of protein C or its cofactor, protein S, has been associated with tissue necrosis following warfarin administration. |
| Pharmaceutical and lifestyle prevention options | Familion® 5-gene profile | Cardiovascular disease: Guides prevention and drug selection for patients with inherited cardiac channelopathies such as Long QT Syndrome (LQTS), which can lead to cardiac rhythm abnormalities. |
| Statins | PhyzioType SINM | Cardiovascular disease: Predicts risk of statin-induced neuro-myopathy, based on a patient's combinatorial genotype for 50 genes. |
| Atorvastatin | LDLR | Cardiovascular disease: "Doses should be individualized according to the recommended goal of therapy. Homozygous Familial Hypercholestremia (10-80mg/day)and heterozygous (10-20mg/day)." |
| Camptosar (irinotecan) | UGTIA1 | 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." |
| Erbitux® (cetuximab) Gefitinib Vectibix® (panitumab) |
EGFR expression | Colon cancer: "Patients enrolled in the clinical studies were required to have...evidence of positive EGFR expression using the DakoCytomation EGFR pharmDx™ test kit." EGFR positive individuals are more likely to respond to the drug than those with reduced EGFR expression. |
| Erbitux® (cetuximab) Gefitinib Vectibix® (panitumab) |
KRAS | Colon cancer: Certain KRAS mutations lead to unresponsiveness to the drug. |
| Erbitux® (cetuximab) and Vectibix® (panitumab) Fluorouracil Camptosar® (irinotecan) |
Target GI™ | Colon cancer: Provides information of the expression of key molecular targets—KRAS, TS, and TOPO1—to guide therapy. |
| Tagretol (carbamazepine) | HLA-B*1502 | Epilepsy and bipolar disorder: Serious dermatologic reactions are associated with the HLA-B*1502 allele in patients treated with carbamazepine. "Prior to initiating Tegretol therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present." |
| Immunosuppressive drugs | AlloMap® gene profile | Epilepsy and bipolar disorder: Monitors patient's immune response to heart transplant to guide immunosuppressive therapy. |
| Ziagen® (abacavir) | HLA-B*5701 | HIV: "Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended." |
| Selzentry® (maraviroc) | CCR5 receptor (1) | HIV: "Selzentry, in combination with other antiretroviral agents, is indicated for treatment experienced adult patients infected with only CCR5-tropic HIV-1 detectable..." |
| Budesonide | IBD Serology 7 | Inflammatory bowel disease: Identifies subset of patients who will benefit from budesonide. |
| Gleevec® (imatinib mesylate) | BCR-ABL | Leukemia: "Gleevec® (imatinib mesylate) is indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive [indicated by presence of BCR-ABL] chronic myeloid leukemia (CML) in chronic phase." |
| Dasatinib | Philadelphia Chromosome | Leukemia: "Dasatinib is indicated for the treatment of adults with Philadelphia chromosomepositive acute lymphoblastic leukemia (Ph+ AL) with resistance or intolerance to prior therapy" |
| Busulfan | Philadelphia Chromosome | Leukemia: "Busulfan is clearly less effective in patients with chronic myelogenous leukemia who lack the Philadelphia (Ph1) chromosome." |
| Purinethol® (mercaptopurine) Thiaguanine Azathioprine |
TPMT | Leukemia: 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..." |
| Tarceva® (erlotinib) | EGFR expression | Lung cancer: The test determines patients most likely to respond. |
| Capecitabine | DPD | Multiple cancers: "Rarely, unexpected severe toxicity (e.g., stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to a deficiency of dihydropyrimidine dehydrogenase (DPD) activity." |
| Pharmaceutical and surgical treatment options and surveillance | MLH1, MSH2, MSH6 | Multiple cancers: Guides surveillance and preventive treatment based on susceptibility risk for colon and other cancers. |
| Chemotherapy | CupPrint™ | Multiple cancers: Determines cancer classification for tumors of unknown primary origin. |
| Chemotherapy | Aviara CancerTYPE ID® | Multiple cancers: Classifies 39 tumor types from tumors of unknown primary origin, using a gene expression profile. |
| Elitek® (rasburicase) | G6PD deficiency | Multiple cancers: "Rasburicase administered to patients with glucose- phosphate dehydrogenase (G6PD) deficiency can cause severe hemolysis. ... It is recommended that patients at higher risk for G6PD deficiency ... be screened prior to starting ELITEK therapy." |
| Drugs metabolized by CYP P450 2C19: Celecoxib, Codeine, Diazepam, Esomeprazole, Nelfinavir, Omeprazole, Pantoprazole, Rabeprazole, Voriconazole 2D6: Acetaminophen, Aripiprazole, Atomoxetine, Carvedilol, Cevimeline hydrochloride, Clozapine, Fluoxetine HCl, Fluoxetine HCL and Olanzapine, Metoprolol, Propranolol, Propafenone, Protriptyline HCl, Risperidone, Tamoxifen, Terbinafine, Thioridazine, Timolol maleate, Tiotropium bromide inhalation, Tolterodine, Tramadol, Venlafaxine |
Amplichip® CYP2D6/CYP2C19 | Multiple diseases: 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." |
| Rifampin Isoniazid Pyrazinamide |
NAT | Multiple diseases: N-acetyltransferase slow and fast acetylators and toxicity- "slow acetylation may lead to higher blood levels of the drug, and thus, an increase in toxic reactions." |
| Rituximab | PGx Predict™: Rituximab | Non-Hodgkin's lymphoma: Detects CD-20 variant (polymorphism in the IgG Fc receptor gene FcgRIIIa) to predict response to cancer drug rituximab. |
| Celebrex® (celecoxib) | CYP2C9 | Pain: "Patients who are known or suspected to be P450 2C9 poor metabolizers based on a previous history should be administered celecoxib with caution as they may have abnormally high plasma levels due to reduced metabolic clearance." |
| Risperdal® (resperidone) Zyprexa® (olanzapine) |
PhyzioType PIMS | Psychiatric disorders: Predicts risk of psychotropic-induced metabolic syndrome, based on a patient's combinatorial genotype for 50 genes. |
| Gleevec® (imatinib mesylate) | c-KIT | Stomach cancer: "Gleevec® is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)." |
Indications in quotes are taken from the therapeutic product label.
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
DPD = dihydropyrimidine dehydrogenase
G6PD = glucose 6 phosphate dehydrogenase HER2 = human epidermal growth factor receptor 2
NAT = N-acetyltransferase
TOPO1 = topoisomerase 1
TPMT = thiopurine S-methyltransferase
TS = thymidylate synthase
UGT1A1 = UDP-glucuronosyltransferase 1A1
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