--First and only companion diagnostic to detect tumor BRCA1/2
alterations, potentially increasing the number of women who are eligible
for Rubraca (rucaparib) therapy--
--FDA approval of FoundationFocus CDxBRCA
marks important progress towards Foundation Medicine's development of a
comprehensive universal companion diagnostic assay across multiple tumor
types to advance precision medicine in oncology--
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Foundation
Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and
Drug Administration (FDA) has approved FoundationFocus™ CDxBRCA
for use as a companion diagnostic to aid in identifying women with
ovarian cancer for whom treatment with Rubraca™ (rucaparib), a therapy
developed by Clovis Oncology, Inc., is being considered. FoundationFocus
CDxBRCA is an FDA-approved tissue-based, genomic assay
that uniquely detects tumor BRCA1 and BRCA2 mutations (may
include both germline (inherited) and somatic (acquired)) in ovarian
cancer. FoundationFocus CDxBRCA may help identify more
women who could benefit from Rubraca therapy as compared to conventional
testing methods that only identify germline BRCA1/2 mutations.
Germline-only BRCA1/2 testing identifies approximately half of
all BRCA1/2 mutations.i,ii
Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as
monotherapy for the treatment of patients with deleterious BRCA
mutation (germline and/or somatic) associated advanced ovarian cancer
who have been treated with two or more chemotherapies, and selected for
therapy based on an FDA-approved companion diagnostic for Rubraca.
"These simultaneous approvals by the FDA represent a step forward for
women with advanced ovarian cancer, an area where there is a tremendous
need for effective therapeutic approaches and efficient ways to identify
those most likely to respond to PARP inhibitor therapy," said Michael
Pellini, M.D., chief executive officer of Foundation Medicine. "This
approval also represents a significant milestone for Foundation
Medicine, one that underscores the quality and value of our molecular
information solutions to inform patient care and to accelerate and
streamline the therapeutic development programs of our biopharmaceutical
partners."
Foundation Medicine and Clovis Oncology closely collaborated on a
regulatory strategy to develop FoundationFocus CDxBRCA
in parallel with the development of Rubraca. Tissue samples taken from
individuals with ovarian cancer who enrolled in rucaparib clinical
trials were analyzed by Foundation Medicine utilizing comprehensive
genomic profiling (CGP) to identify biomarkers associated with a
response to therapy. These molecular signatures of response informed the
development of FoundationFocus CDxBRCA, which was
utilized in Clovis' pivotal trial, ARIEL2, to identify patients and
accelerate recruitment into the study. The companies filed concurrent
pre-market approval (PMA) and new drug application (NDA) submissions
with the FDA earlier this year.
With this FDA approval, FoundationFocus CDxBRCA is the
first validated, tissue-based assay developed from the Quality Systems
Regulations (QSR)-compliant version of Foundation Medicine's CGP assay,
providing uniform analysis of all BRCA1/2 coding exons.
Dr. Pellini continued, "FDA approval of our first companion diagnostic
assay also represents an important advance in our efforts to utilize our
rigorously validated CGP approach to deliver a universal companion
diagnostic assay. We believe this approach may enable the efficient
delivery of personalized cancer care by eliminating the guesswork for
physicians through a comprehensive view of companion diagnostic claims,
as well as potential treatment options based on guidelines, peer
reviewed literature and clinical trials."
As part of the company's effort to develop a universal companion
diagnostic, earlier this year, Foundation Medicine announced that
FoundationOne®, the company's CGP assay for solid tumors, was
accepted by the FDA and the Centers for Medicare and Medicaid Services
(CMS) for Parallel Review. The FDA also granted Foundation Medicine's
request for review as part of its Expedited Access Pathway for
breakthrough devices. If approved, FoundationOne would be an
FDA-approved CGP assay that incorporates multiple companion diagnostics
to support precision medicine in oncology, including an indication for
use as a companion diagnostic across a diverse range of solid tumors,
which is anticipated to include ovarian cancer.
More than 22,000 women will potentially be diagnosed with ovarian cancer
in the U.S. during 2016.iii Ovarian cancer is the leading
cause of female gynecologic cancer-related deathsiv and one
in four women with ovarian cancer have a germline or somatic BRCA
mutation.ii
About FoundationFocus CDxBRCA
Intended Use: FoundationFocus CDxBRCA is a next
generation sequencing test for qualitative detection of BRCA1 and BRCA2
(BRCA1/2) alterations in formalin-fixed paraffin-embedded (FFPE)
ovarian tumor tissue. The FoundationFocus CDxBRCA assay
detects sequence alterations in BRCA1/2 genes. Results of the
test are used as an aid in identifying ovarian cancer patients for whom
treatment with Rubraca™ (rucaparib) is being considered. If a patient is
positive for any of the deleterious alterations specified in the BRCA1/2
classification, the patient may be eligible for treatment with Rubraca.
This assay is to be performed at Foundation Medicine, Inc., a single
laboratory site located at 150 Second Street, Cambridge, MA 02141. For
more information about FoundationFocus CDxBRCA assay,
visit http://www.foundationmedicine.com/focus.
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 (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks and
FoundationFocus™ is a 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 any benefits of
FoundationFocusCDxBRCA for women with advanced
ovarian cancer; the ability of FoundationFocusCDxBRCA
to identify more women who could benefit from PARP inhibitor therapy as
compared to conventional testing methods that only identify germline
BRCA1/2 mutations; the scope and timing of any approval of FoundationOne
as a medical device by the FDA, and the inclusion of a companion
diagnostic for ovarian cancer; the scope and timing for a coverage
decision by CMS for FoundationOne; and the ability of FoundationFocusCDxBRCA
to enable an efficient and personalized approach to cancer care. 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 FoundationFocusCDxBRCA will not identify
up to twice as many women who could benefit from PARP inhibitor therapy
over germline-only conventional testing methods; the FDA will approve
other validated, tissue-based assays that provide uniform analysis of
all BRCA 1/2 coding exons; Foundation Medicine is not able to make
FoundationFocusCDxBRCA accessible to physicians
and patients due to commercial and financial obstacles; FDA does not
approve FoundationOne as a medical device or CMS does not cover
FoundationOne under the Medicare reimbursement program; in conducting
the parallel review of FoundationOne, either the FDA or CMS is delayed
in the completion of its review; 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, 2015, 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.
i Hennessy BTJ, et al. Somatic mutations in BRCA1 and BRCA2
could expand the number of patients that benefit from poly (ADP ribose)
polymerase inhibitors in ovarian cancer. JCO. 2010;28(22):3570-6.
ii Pennington KP, et al. Germline and somatic mutations in
homologous recombination genes predict platinum response and survival in
ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res.
2013;20(3):764-75.
iiiAmerican Cancer Society. 2016, February 4. Overview of
ovarian cancer. Retrieved from http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-key-statistics.
ivOvarian Research Fund Alliance. (n.d.) Statistics.
Retrieved from https://ocrfa.org/patients/about-ovarian-cancer/statistics/.

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Media Contact:
Pure Communications, Inc.
Dan Budwick,
973-271-6085
dan@purecommunicationsinc.com
or
Investor
Contact:
Foundation Medicine, Inc.
Kimberly Brown, 617-418-2215
ir@foundationmedicine.com
Source: Foundation Medicine, Inc.
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