Companion Diagnostics Underscore Need for Targeted Clinical Trials

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Caring for patients with breast and colorectal cancer, gastrointestinal stromal tumors, melanoma, and non–small cell lung cancer (NSCLC) increasingly means delivering personalized medicine.

Related: When Less is More: Personalized Care in Cancer Patients

This is due, in part, to the burgeoning arsenal of U.S. Food and Drug Administration (FDA)–approved companion diagnostic devices, designed specifically to identify the appropriate treatment for patients based on their respective, targeted oncology agent counterparts (Table 1).1

In May 2013, two new companion diagnostics were approved: the cobas® EGFR Mutation Test and the THxIDTM BRAF Kit. The cobas® EGFR Mutation Test can detect metastatic NSCLC tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations in effort to guide treatment with erlotinib (TARCEVA®).2 The THxIDTM BRAF Kit is for use in patients with unresectable or metastatic melanoma BRAF V600E or V600K mutations who are eligible for potential treatment with one of two kinase inhibitors, dabrafenib (TAFINLAR®) or trametinib (MEKINIST®).3,4

Table 1. Companion Diagnostic Devices1

Drug Trade Name (Generic) Device Trade Name
Device Manufacturer
 Indications for Use
ERBITUX® (cetuximab) therascreen® KRAS RGQ PCR Kit
Qiagen Manchester, Ltd.
Identifying patients with colorectal cancer for treatment with cetuximab based on a KRAS no-mutation-detected test result
ERBITUX (cetuximab); VECTIBIX® (panitumumab)
DAKO EGFR PharmDx™ Kit
Dako North America, Inc.
Identifying patients with colorectal cancer eligible for treatment with cetuximab or panitumumab
GILOTRIF™ (afatinib) therascreen EGFR RGQ PCR Kit
Qiagen Manchester, Ltd. Selecting patients with NSCLC for whom afatinib is indicated
GLEEVEC® (imatinib mesylate)  DAKO C-KIT PharmDx™  Dako North America, Inc.  Differential diagnosis of GIST and subsequent identification of patients eligible for treatment with imatinib mesylate 
HERCEPTIN® (trastuzumab)   INFORM HER2/neu  Ventana Medical Systems, Inc.  Adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priori invasive, localized breast carcinoma, and who are lymph-node negative
PathVysion™ HER2 DNA Probe Kit   Abbott Molecular Inc.  Adjunct to existing clinical and pathologic information currently used as prognostic factors in stage 2, node-positive patients with breast cancer; aids in predicting DFS and OS in patients with stage 2 node-positive cancer treated with adjuvant CAF chemotherapy; aids in assessment of patients for whom trastuzumab treatment is being considered
PATHWAY anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody   Ventana Medical Systems, Inc.  Assessing patients with breast cancer for whom trastuzumab treatment is being considered
 InSite HER2/neu KIT  Biogenex Laboratories Inc.  Assessing patients with breast cancer for whom trastuzumab therapy is being considered
SPOT-Light® HER2 CISH Kit   Life Technologies Inc.  Assessing patients for whom trastuzumab treatment is being considered; adjunct to clinicopathological information currently being used as part of the management of patients with breast cancer
 Bond™ Oracle™ HER2 IHC System  Leica Biosystems  Assessing patients for whom trastuzumab treatment is being considered
HER2 CISH PharmDx™ Kit
 Dako Denmark A/S  Assessing patients for whom trastuzumab is being considered; adjunct to clinicopathologic information currently used for estimating prognosis in patients with stage 2, node-positive breast cancer
INFORM HER2 Dual ISH DNA Probe Cocktail   Ventana Medical Systems, Inc.  Assessing patients for whom trastuzumab treatment is being considered
HERCEPTIN
(trastuzumab)
;
PERJETA® (pertuzumab) 
 HERCEPTEST™  Dako Denmark A/S Assessing patients for whom trastuzumab treatment is being considered and for patients with breast cancer for whom pertuzumab treatment is being considered 
HER2 FISH PharmDx™ Kit   Dako Denmark A/S  Assessing patients for whom trastuzumab treatment is being considered and for patients with breast cancer for whom pertuzumab treatment is being considered; adjunct to clinicopathologic information currently used for estimating prognosis in patients with stage 2, node-positive breast cancer
MEKINIST™ (trametinib); TAFINLAR® (dabrafenib)   THxIDTM BRAF Kit  bioMérieux Inc.  Selecting patients with melanoma whose tumors carry the BRAF V600E mutation for treatment with dabrafenib and whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib
TARCEVA® (erlotinib)  cobas® EGFR Mutation Test  Roche Molecular Systems, Inc.   Selecting patients with metastatic NSCLC for whom erlotinib is indicated
 XALKORI® (crizotinib)  Vysis ALK Break Apart FISH Probe Kit  Abbott Molecular Inc.  Detecting rearrangements involving the ALK gene via FISH in FFPE NSCLC tissue specimens to aid in identifying patients eligible for treatment with crizotinib
ZELBORAF® (vemurafenib)  cobas® 4800 BRAF V600 Mutation Test   Roche Molecular Systems, Inc. Selecting patients with melanoma whose tumors carry the BRAF V600E mutation for treatment with vemurafenib 
Abbreviations: NSCLC, non-small cell lung cancer; GIST, gastrointestinal stromal tumors; DFS, disease-free survival; OS, overall survival; CAF, cyclophosphamide, doxorubicin, and 5-fluorouracil; ALK, anaplastic lymphoma kinase; IHC, immunohistochemistry; CISH, chromogenic in situ hybridization; FISH, fluorescence in situ hybridization; FFPE, formalin-fixed paraffin-embedded.

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