Foundation Medicine’s liquid biopsy test can
now be used in addition to its tissue biopsy test,
FoundationOne®CDx, to identify more patients for whom AKEEGA® may
be appropriate
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
AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech,
Inc, a Johnson & Johnson company, the first and only
FDA-approved dual-action tablet combining PARP inhibition and
hormone therapy for the treatment of adult patients with
deleterious or suspected deleterious BRCA-mutated metastatic
castration-resistant prostate cancer (mCRPC).1 This decision from
the FDA follows the approval of FoundationOne®CDx, Foundation
Medicine’s tissue-based comprehensive genomic profiling (CGP) test,
for the same therapy and indication in August 2023.
Prostate cancer is one of the most common cancers in men.2
BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of
the disease,3 occurring in approximately 11% of diagnoses.4 Despite
progress in developing new treatment options for this condition,
BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and
patients often face a poor prognosis.5
While some BRCA1 and BRCA2 mutations are germline, somatic
mutations are more common.4 While tumor tissue testing is the gold
standard for identifying patients with BRCA1 or BRCA2 mutations in
prostate cancer, not all patients with mCRPC have sufficient tumor
tissue available for testing.6 With this approval, healthcare
providers can now leverage a minimally invasive liquid biopsy to
identify additional patients with BRCA mutations who may benefit
from AKEEGA®.
“We know how challenging it can be to obtain a tissue sample for
testing in advanced cancers such as mCRPC, making liquid biopsy an
incredibly important tool in a provider’s toolbox for the
development of personalized treatment plans for their patients,”
said Mia Levy, M.D., Ph.D., chief medical officer at Foundation
Medicine. “The approval of our liquid biopsy test, along with the
previous approval for our tissue biopsy test, will enable more
patients to access this important therapy option. Additionally,
with the ability to leverage a liquid-based test and reflex to a
tissue-based test if needed, healthcare providers can feel
confident they have accurate genomic information at their
fingertips to guide treatment decisions for patients.”
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), prostate cancer, breast cancer, and
colorectal cancer, plus a pan tumor indication specific to
NTRK1/2/3 fusions.
With today’s approval, Foundation Medicine is the only company
that has five FDA-approved companion diagnostic indications for
prostate cancer.7 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.8
“Men with aggressive prostate cancer need and deserve more
options,” said Courtney Bugler, President and CEO of ZERO Prostate
Cancer. “We applaud Foundation Medicine’s liquid biopsy test
because it empowers patients and families with more tools that can
potentially help them lead longer, fuller lives.”
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 LinkedIn
and X.
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 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 genomic alteration 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.
1 AKEEGA Prescribing Information. Horsham,
PA: Janssen Biotech, Inc.
2 Cancer.net. Prostate Cancer: Statistics.
Updated March 2023. Accessed May 13, 2024.
https://www.cancer.net/cancer-types/prostate-cancer/statistics
3 Castro E, Eeles R. The role of BRCA1 and
BRCA2 in prostate cancer. Asian J Androl. 2012;14(3):409-414.
doi:10.1038/aja.2011.150
4 Valsecchi AA, Dionisio R, Panepinto O,
et al. Frequency of Germline and Somatic BRCA1 and BRCA2 Mutations
in Prostate Cancer: An Updated Systematic Review and Meta-Analysis.
Cancers. 2023; 15(9):2435.
https://doi.org/10.3390/cancers15092435
5 Messina C, Cattrini C, Soldato D, et al.
BRCA Mutations in Prostate Cancer: Prognostic and Predictive
Implications. J Oncol. 2020;2020:4986365. Published 2020 Sep 7.
doi:10.1155/2020/4986365
6 Chi KM, Barnicle A, Sibilia C, et al.
Detection of BRCA1, BRAC2 and ATM alterations in matched tumor
tissue and circulating tumor DNA in patients with prostate cancer
screened in PROfound. Clin Cancer Res. 2023;29(1):81-9.
https://doi.org/10.1158/1078-0432.CCR-22-0931
7 Data on File, Foundation Medicine, Inc.
2024
8 Data on File, Foundation Medicine, Inc.,
data as of March 2024
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Media: Danielle Johns, 845-304-7408
newsroom@foundationmedicine.com