[December 01, 2017] |
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FDA Approves Foundation Medicine's FoundationOne CDx™, the First and Only Comprehensive Genomic Profiling Test for All Solid Tumors Incorporating Multiple Companion Diagnostics
Foundation
Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and
Drug Administration (FDA) approved FoundationOne CDx™, the
company's comprehensive companion diagnostic test for solid tumors.
FoundationOne CDx is intended for use by health care professionals to
help inform cancer treatment management in accordance with professional
guidelines for patients with solid tumors. The first and only
FDA-approved test of its kind for all solid tumors, FoundationOne CDx is
a diagnostic test that acts as:
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Foundation Medicine is headquartered in Cambridge, MA (Photo: Business Wire)
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a comprehensive companion diagnostic to identify patients who may
benefit from treatment with specific FDA-approved targeted therapies;
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a comprehensive genomic profiling (CGP) test that includes genomic
biomarkers to help inform the use of other targeted oncology
therapies, including immunotherapies;
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a tool for physicians that identifies patient opportunities for
clinical trial participation; and,
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an FDA-approved platform for companion diagnostic development for
biopharma companies developing precision therapeutics.
FoundationOne CDx assesses all classes of genomic alterations in 324
genes known to drive cancer growth, providing potentially actionable
information to help guide treatment decisions. It is also indicated as a
companion diagnostic for patients with certain types of non-small cell
lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or
breast cancer to identify those patients who may benefit from treatment
with one of 17 on-label targeted therapies, including 12 therapies
currently approved as first-line therapy for their respective
indications. FoundationOne CDx also reports genomic biomarkers, such as
microsatellite instability (MSI (News - Alert)) and tumor mutational burden (TMB), that
can help inform the use of immunotherapies; genomic alterations in other
genes relevant to patient management; and, relevant clinical trial
information.
Based on previous CGP testing conducted by Foundation Medicine, it is
estimated that approximately 1 in 3 patients across five common advanced
cancers are expected to match with an FDA approved therapy.1 The
number of matched on-label therapies indicated on FoundationOne CDx is
expected to increase over time as Foundation Medicine and its biopharma
partners pursue FDA approval for additional companion diagnostics on the
platform. Today, approximately 50% of new cancer drugs in development
are projected to have a companion biomarker.2
Concurrent with FDA approval, the Centers for Medicare and Medicaid
Services (CMS) issued a preliminary National Coverage Determination
(NCD) for FoundationOne CDx. The draft NCD would provide coverage for
FDA-approved companion diagnostic claims, as well as a pathway for
additional coverage with evidence development in other solid tumor
types. The final policy is expected to issue during the first quarter of
2018 following public comment of the preliminary NCD and an
administrative period.
"Today we know that many people with cancer do not receive biomarker
testing, let alone the comprehensive genomic testing they need to be
efficiently matched to the best therapeutic option," said Andrea Ferris,
President and CEO of LUNGevity Foundation. "This FDA approval means
that, in one test, patients can access therapies where companion
diagnostics have been established for their cancer while getting a broad
tumor profile that can identify the therapies and clinical trials they
could most benefit from. Along with the preliminary national coverage
determination, this has the potential to democratize next-generation
sequencing, lowering the barriers for patients treated in the community
to access these biomarker-driven treatments."
"Comprehensive genomic profiling is the gateway to precision medicine.
This decision from the FDA and CMS, which may lead to coverage for
Medicare patients, represents an important step forward in improving
patient and clinician access to precision medicine - both in setting a
new quality standard for this type of testing and offering potentially
improved healthcare coverage," said Ankur R. Parikh, DO, Medical
Director of Precision Medicine, Cancer
Treatment Centers of America. "Accessto important genomic
information is a critical step in being able to offer innovative and
targeted treatment options."
FoundationOne CDx results are delivered in an integrated report that
identifies alterations matched to FDA approved therapies, identifies
additional alterations in genes known to drive cancer growth, furnishes
information about genomic biomarkers, including MSI and TMB, provides
relevant clinical trial information, and includes interpretive content
developed in accordance with professional guidelines in oncology for
patients with any solid tumor.
"Today's historic parallel review decision from the FDA and CMS
represents a major advancement in personalized cancer care," said Troy
Cox (News - Alert), chief executive officer at Foundation Medicine. "Physicians will
have an FDA-approved test for all solid tumors in their toolkit that can
inform targeted and immunotherapy selection, as well as identify patient
opportunities for clinical trial participation. Beyond its implications
for patient care, we expect that FoundationOne CDx will provide
biopharma companies with an FDA-approved platform that can help
accelerate drug development and enable personalized oncology care. On
behalf of the Foundation Medicine team, I'd like to thank FDA and CMS
for their leadership and collaboration as we continue to work through
the parallel review process with a shared mission of transforming cancer
care."
FoundationOne CDx is the first solid tumor comprehensive genomic
profiling test reviewed by the FDA and CMS in their Parallel Review
program. FDA approval was based on analytic validation and concordance
studies with FDA-approved assays. FoundationOne CDx is expected to be
commercially available following finalization of the NCD from CMS.
Conference Call and Webcast Details Foundation Medicine will
conduct a conference call to discuss FDA approval and the draft national
coverage determination from CMS for FoundationOne CDx on Friday,
December 1 at 8:30 a.m. ET. To access the conference call via phone,
dial 1-877-270-2148 from the United States and Canada, or dial
1-412-902-6510 internationally, and for either number reference
Foundation Medicine. Dial in approximately ten minutes prior to the
start of the call. The live, listen-only webcast of the conference call
may be accessed by visiting the investors section of the company's
website at investors.foundationmedicine.com.
A replay of the webcast will be available shortly after the conclusion
of the call and will be archived on the company's website for two weeks
following the call.
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. The test is intended as
a companion diagnostic to identify patients who may benefit from
treatment with the targeted therapies listed below in accordance with
the 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. The
FoundationOne CDx assay is a single-site assay performed at Foundation
Medicine, Inc.
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EGFR exon 19 deletions and EGFR exon 21 L858R alterations,
which may indicate efficacy of erlotinib, afatinib or gefitinib in
patients with NSCLC.
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EGFR exon 20 T790M alterations which may indicate efficacy of
osimertinib in NSCLC patients
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ALK rearrangements which may indicate efficacy of crizotinib,
alectinib or certinib in NSCLC patients
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BRAF V600E which may indicate efficacy of dabrafenib in combination
with trametinib in NSCLC patients
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BRAF V600E which may indicate efficacy of vemurafenib or
dabrafenib in melanoma patients
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BRAF V600E and V600K which may indicate efficacy of trametinib
or cobimetinib in combination with vemurafenib in melanoma patients
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ERBB2 (HER2) amplification which may indicate efficacy of
trastuzumab, pertuzumab orado-trastuzumab-emtansine in patients with
breast cancer
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KRAS wild-type (absence of mutations in codons 12 and 13) which
may indicate efficacy of cetuximab in patients with colorectal cancer
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KRAS wild-type (absence of mutations in exons 2, 3 and 4) and NRAS
wild-type (absence of mutations in exons 2, 3 and 4) which may
indicate efficacy of panitumumab in patients with colorectal cancer
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BRCA1/2 alterations which may indicate efficacy of rucaparib in
patients with ovarian cancer
For more information about FoundationOne CDx, visit http://www.FoundationMedicine.com.
About Foundation Medicine Foundation Medicine (NASDAQ:FMI)
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 http://www.FoundationMedicine.com
or follow Foundation Medicine on Twitter (News - Alert) (@FoundationATCG).
Foundation Medicine® is a registered
trademark of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for Foundation
Medicine This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements regarding
the ability of FoundationOne CDx to enhance patient access to targeted
therapies, immunotherapies, and clinical trials, including the number of
patients who will be matched to an on-label therapy; the ability of a
comprehensive genomic profiling assay, including FoundationOne CDx, to
improve patient outcomes; the benefits of our products to physicians,
biopharmaceutical companies, payers, and patients in the treatment of
cancer and personalized cancer care, including whether the number of
on-label therapies indicated on FoundationOne CDx will increase over
time; the benefits provided by an FDA-approved and CMS-covered
FoundationOne CDx assay; any anticipated adoption of FoundationOne CDx
for patient treatment; potential healthcare coverage of FoundationOne
CDx by CMS for patients, including Medicare and Medicare Advantage
patients; the scope and timing of any coverage decision by CMS,
including the timing of issuance of any final NCD; and the timing of any
launch of FoundationOne CDx. All such forward-looking statements are
based on management's current expectations of future events and are
subject to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include the risks that CMS does not issue a final NCD or
issues a final NCD with a revised scope of coverage; CMS is delayed in
the completion of the Parallel Review process; Foundation Medicine is
not able to provide FoundationOne CDx for commercial use in the manner
or on the timeline currently anticipated by management; Foundation
Medicine is unable to sustain or grow relationships with hospitals,
physicians, and biopharmaceutical partners; and the risks described
under the caption "Risk Factors" in Foundation Medicine's Annual Report
on Form 10-K for the year ended December 31, 2016, which is on file with
the Securities and Exchange Commission, as well as other risks detailed
in Foundation Medicine's subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of the
date of the release, and Foundation Medicine undertakes no duty to
update this information unless required by law.
1 Estimates are projections based on a genomic database of
patients with non-small cell lung cancer (NSCLC), melanoma, colorectal
cancer, ovarian cancer or breast cancer who have received CGP testing
from Foundation Medicine as of August 2017; these are the five cancer
types for which FoundationOne CDx is approved to detect alterations that
have associated on-label FDA approved therapies. 2
Developments in Cancer Treatments, Market Dynamics, Patient Access and
Value - Global Oncology Trend Report 2015. IMS Institute for Healthcare
Informatics (News - Alert). Available at: http://keionline.org/sites/default/files/IIHI_Oncology_Trend_Report_2015.pdf.
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