FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for ALUNBRIG® (brigatinib) to Identify Patients with ALK positive Metastatic Non-Small Cell Lung Cancer

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for ALUNBRIG® (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now able to detect ALK+ mNSCLC and identify patients who may be appropriate for treatment with ALUNBRIG which is approved as a first-line or later-line therapy.

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 percent of the estimated 1.8 million new cases of lung cancer diagnosed globally each year. ^{1 2} Approximately three to five percent of patients with NSCLC have a rearrangement in the ALK gene.³

“This approval reinforces the importance of comprehensive genomic profiling in patient care and confirms its value in guiding treatment decisions at diagnosis of metastatic non-small cell lung cancer,” said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. “We’re proud to partner with Takeda to ensure patients with this serious condition have access to this important treatment option.”

FoundationOne CDx, which now has 28 companion diagnostic claims, is the first and only FDA-approved tissue-based broad companion diagnostic that is clinically and analytically validated for solid tumors. This latest approval reinforces FoundationOne CDx’s ability to detect ALK rearrangements, which can be missed with alternate testing methods.

“It’s exciting to see continued advancement in personalizing medicine,” said Gina Hollenbeck, President of ALK Positive. “As a non-small cell lung cancer patient myself who has experienced brain metastases, I know how important it can be to find the right treatment at the right time, especially in the first line.”

Foundation Medicine and Takeda entered into an agreement to develop companion diagnostics for therapies in its late-stage lung portfolio in September 2020.

“We are excited by the approval of FoundationOne CDx as a companion diagnostic for ALUNBRIG, an important milestone in the diagnosis and treatment of people living with ALK+ non-small cell lung cancer,” said Dion Warren, head, U.S. Oncology Business Unit, Takeda. “The approval of FoundationOne CDx to inform treatment with ALUNBRIG is the first of three companion diagnostics in development as part of our ongoing partnership between Foundation Medicine and Takeda aimed at addressing the urgent need for broad access to genomic tests, and expanding treatment options for people with lung cancer.”

ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target ALK molecular alterations. ALUNBRIG is approved in the U.S., European Union (EU) and Japan as a first-line treatment for patients with ALK+ mNSCLC previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 40 countries, including the U.S., Canada and the EU, for the treatment of people living with ALK+ mNSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.

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 http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

ALUNBRIG® is a registered trademark of Takeda

Source: Foundation Medicine

¹ World Health Organization. Latest Global Cancer Data. https://www.who.int/cancer/PRGlobocanFinal.pdf. Accessed May 11, 2019.

² American Cancer Society. What is Non-Small Cell Lung Cancer? https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.

³ Gainor JF, Varghese AM, Ou SH, et al. Clin Cancer Res. 2013;19(15):4273-81.

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