U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) to Identify Patients with HR-Positive, HER2-Negative Advanced Breast Cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 AstraZeneca’s Truqap^™ (capivasertib) in combination with Faslodex^® (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Approximately 70% of advanced breast cancers are HR-positive,¹ and PI3K-AKT pathway alterations occur in the tumors of up to 50% of these HR-positive patients.² Endocrine therapy, the mainstay first line treatment in combination with CDK4/6 inhibition, does not stop disease progression for most of these patients and treatment thereafter remains a clinical challenge. CAPItello-291, a double-blind, phase 3, randomized trial showed that the addition of capivasertib to fulvestrant therapy resulted in a significant improvement in progression-free survival among patients with HR-positive, HER2-negative PIK3CA/AKT1/PTEN-altered advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor.³ FoundationOne CDx will be the first FDA-approved test to identify this new, prevalent subset of breast cancer patients for treatment with capivasertib.⁴

“We are thrilled to see an additional therapeutic option approved to help treat the high number of HR-positive breast cancer patients,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “This companion diagnostic approval adds to the growing utility of Foundation Medicine’s high-quality diagnostic test portfolio in treating advanced breast cancer.”

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 35 companion diagnostic indications, five of which are in breast cancer.

“The prevalence of HR-positive breast cancer means the introduction of new targeted treatment options for this patient population will have an exponential impact,” said Shehzin Tietjen, Associate Director, Corporate Relations at Living Beyond Breast Cancer. “Biomarker testing is such an important component of getting patients on the right therapy for their specific cancer, and we’re encouraged to see additional companion diagnostic indications being approved to help increase patient access to precision medicine.”

Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

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

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.

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.

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^1 Walsh, E. et al. Semin Oncol. 2020 Aug; 47(4): 187–200. Published online 2020 Jun 3. doi: 10.1053/j.seminoncol.2020.05.010

^2 Turner, N. et al. Breast Cancer Res Treat. 2022; 191(3): 565–576. Published online 2021 Dec 3. doi: 10.1007/s10549-021-06450-x

^3 Turner NC, et al. N Engl J Med 2023; 388:2058-2070, DOI: 10.1056/NEJMoa2214131

^4FDA List of Cleared and Approved CDx Devices. Accessed on November 19, 2023: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

Source: Foundation Medicine