This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: cobas® EGFR Mutation Test v2
PMA Applicant: Roche Molecular Systems, Inc.
Address: 4300 Hacienda Drive, Pleasanton, CA 94588, USA
Approval Date: June 1, 2016
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150047a.pdf
What is it? The cobas® EGFR Mutation Test v2 is an automated molecular assay
designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC). In normal tissue, the EGFR protein transmits signals in cells to regulate cell growth and cell death. Mutations in the EGFR gene result in abnormal functioning of the EGFR protein and stimulate cancer cell growth in NSCLC.
The first version (v1) of the cobas® EGFR Mutation Test was approved by FDA on May 14, 2013 to detect different specific EGFR mutations (i.e., exon 19 deletions and exon 21 L858R substitution mutations) in tumor tissue specimens to aid physicians in identifying patients who may be treated first with TARCEVA® (erlotinib), an EGFR inhibitor drug. The second version of the test (cobas® EGFR Mutation Test v2) was approved on November 13, 2015. This approval added the T790M mutation to the clinically relevant mutations to aid physicians in selecting patients with metastatic NSCLC whose tumor tissue specimens are positive for the EGFR T790M mutation and whose disease has progressed following treatment with EGFR specific drugs, such as TARCEVA® (erlotinib) for treatment with TAGRISSO™ (osimertinib).
This new approval of the cobas® EGFR Mutation Test v2 is to aid physicians in selecting patients with metastatic NSCLC with specific EGFR treatment mutations (i.e., exon 19 deletions and exon 21 L858R substitution mutations) in plasma specimens, also called liquid biopsy specimens, to aid physicians in identifying patients who may be treated first with TARCEVA® (erlotinib). This new specimen may benefit patients who may be too ill or unable to provide a tumor specimen.
How does it work?
- NSCLC tumors shed tumor DNA into the circulation. Specific mutations present in this circulating tumor DNA (ctDNA) can be detected from blood specimens.
- The doctor takes a tube of blood from a patient with NSCLC. The blood is spun to separate the blood cells from the plasma portion.
- ctDNA is isolated from a patient’s plasma specimen and mixed with reagents that specifically detect, bind to, and make copies of the tumor’s EGFR gene. This reaction produces fluorescence, which is then measured to determine presence or absence of the specific EGFR mutations in the plasma specimen.
- The presence of specific mutations [exon 19 deletion or exon 21 (L858R) substitution mutations] is detected in NSCLC patient plasma specimens indicates the patient is eligible for treatment with TARCEVA® (erlotinib). If neither of these mutations is detected, then the patient’s eligibility for treatment with TARCEVA® (erlotinib) should be determined by testing their tumor tissue specimen, unless a tumor biopsy cannot be obtained.
- The doctor takes a new small amount of tumor tissue from a patient’s NSCLC and examines it (biopsy).
- The tumor tissue is then embedded in a block of paraffin wax. A thin slice of the tumor tissue is cut from the block for use in the test.
- DNA is then isolated from a patient’s tumor biopsy and mixed with reagents as above to detect the presence or absence of the specific EGFR mutations in the tumor tissue specimen.
- The presence of the exon 19 deletion or exon 21 (L858R) substitution mutations in NSCLC patient’s tumor tissue specimen indicates the patient is eligible for treatment with TARCEVA® (erlotinib). If the T790M mutation is detected in a patient’s tumor biopsy then the patient is eligible for treatment with TAGRISSO™ (osimertinib).
When is it used? To determine if a patient’s NSCLC characteristics suggest that a patient might be a candidate for TARCEVA® (erlotinib) or TAGRISSO™ (osimertinib) treatment.
What will it accomplish? The cobas® EGFR Mutation Test v2 helps to determine whether metastatic NSCLC patients should be considered for treatment with TARCEVA® (erlotinib) or TAGRISSO® (osimertinib) , which may prolong their life.
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available at: