May 04, 2023 07:01 AM Eastern Daylight Time
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., a leader in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for EXKIVITY® (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. For full Indication, Important Safety Information and link to the Prescribing Information, please see ‘About Exkivity’ below. FoundationOne Liquid CDx is the only blood-based comprehensive genomic profiling (CGP) test that is FDA-approved to detect EGFR exon 20 insertion mutations to identify patients who may be appropriate for treatment with EXKIVITY.
“The approval of this indication for Foundation Medicine’s blood-based companion diagnostic test is another important step forward to expand the identification of patients in the U.S. with this rare cancer and improve access for people who may benefit from treatment with EXKIVITY, including those unable to undergo tumor biopsy.”Tweet this
Non-small cell lung cancer is the most common form of lung cancer, accounting for 80-85% of lung cancer diagnoses.1 Approximately 1-2% of patients with NSCLC have EGFR exon 20 insertion mutations, which are more common in Asian populations compared to Western populations.2-6
“EGFR exon 20 insertion-positive NSCLC is a rare and historically underdiagnosed disease that requires a targeted treatment approach at the molecular level due to its unique mutation,” said Stefanie Granado, head, U.S. Oncology Business Unit, Takeda. “The approval of this indication for Foundation Medicine’s blood-based companion diagnostic test is another important step forward to expand the identification of patients in the U.S. with this rare cancer and improve access for people who may benefit from treatment with EXKIVITY, including those unable to undergo tumor biopsy.”
Foundation Medicine’s two FDA-approved tests meet rigorous analytical and clinical validation standards. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes for genomic alterations that cause cancer to grow.
“Cancer is an incredibly complex disease, so it’s critical that oncologists leverage companion diagnostics, which are high-quality, well-validated genomic tests, to inform treatment decisions for their patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “We’re proud of the work we’ve done with Takeda to develop blood and tissue-based companion diagnostics for therapies in their precision oncology pipeline, including this recent approval for EXKIVITY.”
“People living with rare forms of lung cancer like EGFR exon 20 insertion mutated NSCLC often face limited treatment options,” said Danielle Hicks, chief patient officer at GO2 for Lung Cancer. “It’s encouraging to see continued progress toward improving access to new treatment options for patients living with advanced non-small cell lung cancer.”
About FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as 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. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other 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.
Source: https://www.businesswire.com/news/home/20230504005202/en/FoundationOne%C2%AELiquid-CDx-Receives-FDA-Approval-as-a-Companion-Diagnostic-for-EXKIVITY%C2%AE-mobocertinib-to-Identify-Patients-with-EGFR-Exon-20-Insertion-Mutations-in-Advanced-Non-Small-Cell-Lung-Cancer