This is the blood-based test’s first group approval, and improves physicians’ ability to identify patients in this population for treatment with certain FDA-approved tyrosine kinase inhibitors
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved its FoundationOne®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors (TKI) approved by the FDA for this indication. Group approvals are granted when evidence is sufficient to conclude that a companion diagnostic is appropriate for use with a specific group of therapies, rather than specific products.1
Specific segments of the DNA molecule, called exons, contain information that helps to code proteins. EGFR mutations seen in NSCLC patients are due to mutations within two specific exons—deletions in exon 19 and substitutions in exon 21.2 Since EGFR mutations are the second most common drivers of tumor growth in NSCLC patients, the ability to pinpoint two of the largest catalysts of cancer growth in these patients provides oncologists with more insight for their targeted treatment planning.
“For NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” says Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne®CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process. These efforts help to maintain the high-quality standards and rigor of the process, while streamlining the approach to developing TKIs to get these treatments to patients faster.”
As a companion diagnostic for all therapies in this group targeting these mutations in NSCLC, FoundationOne Liquid CDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.
The current therapies for which FoundationOne Liquid CDx is a companion diagnostic under the group approvals are Tarceva (erlotinib), Tagrisso (osimertinib) and Iressa (gefitinib). Moving forward, FoundationOne Liquid CDx will automatically become a companion diagnostic for future TKIs within this group for NSCLC that are approved by the FDA.
About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.f1cdxlabel.com.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
1 U.S. Food and Drug Administration. “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products.” https://www.fda.gov/media/120340/download
2 Peter T. Harrison, Simon Vyse, Paul H. Huang. “Rare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer.” https://www.sciencedirect.com/science/article/pii/S1044579X19303025
Source: Foundation Medicine
Abigail Alderman, 781-534-3210
Source: Foundation Medicine