U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Pfizer's BRAFTOVI® (encorafenib) in Combination With Cetuximab to Identify Patients With BRAF V600E Alterations in Metastatic Colorectal Cancer

Foundation Medicine Inc. 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 BRAFTOVI® (encorafenib) in combination with cetuximab which is currently FDA-approved for adult patients with previously treated metastatic colorectal cancer (mCRC) harboring a BRAF V600E alteration. This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling (CGP) test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab.

Colorectal cancer is one of the most common and deadly cancers globally.¹ BRAF V600E alterations are estimated to occur in approximately 8% of patients with metastatic CRC.² Historically, there have been limited treatment options available, so patients with this condition generally face a poor prognosis. ^3-4 Pfizer's BRAFTOVI in combination with cetuximab is the first and only FDA-approved targeted therapy regimen for adults with BRAF V600E-mutated mCRC after prior therapy.^5-9

From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

"Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this difficult to treat condition."

"As the second leading cause of cancer-related deaths for men and women combined, colorectal cancer has had a devastating impact on so many people," said Michael Salienza, CEO at Colorectal Cancer Alliance. "We're encouraged by the ongoing progress happening in colorectal cancer care, and believe this approval is an important milestone in delivering broader access to more treatment options."

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 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.

Source: Foundation Medicine

1. Mauri, G., Vitiello, P.P., Sogari, A. et al. Liquid biopsies to monitor and direct cancer treatment in colorectal cancer. Br J Cancer 127, 394?407 (2022). https://doi.org/10.1038/s41416-022-01769-8
2. Djanani A, Eller S, Öfner D, Troppmair J, Maglione M. Int J Mol Sci. 2020;21(23):9001.
3. Kopetz S, Grothey A, Yaeger R, et al. N Engl J Med. 2019;381(17):1632-1643.
4. Van Cutsem E, Cervantes A, Adam R, et al. Ann Oncol. 2016;27(8):1386-1422.
5. BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2022.
6. Erbitux® (cetuximab) Prescribing Information. Eli Lilly and Company; 2021.
7. Center for Drug Evaluation and Research. Approved Drugs - Hematology/Oncology (Cancer) Approvals & Safety Notifications. Internet Archive Wayback Machine. Accessed March 6, 2020. http://wayback.archive-it.org/7993/20170111064250/http:/www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm
8. Center for Drug Evaluation and Research. Approved Drugs - Hematology/Oncology (Cancer) Approvals & Safety Notifications. US Food and Drug Administration. Accessed March 6, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
9. Center for Drug Evaluation and Research. Oncology (Cancer) / Hematologic Malignancies Approval Notifications. US Food and Drug Administration. Accessed August 5, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications