Myriad Genetics Submits First Module of the Premarket Approval Application to FDA for the myChoice® HRD CDx Test
09 April 2019 - 9:05PM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized
medicine, today announced that it has submitted the first module of
its premarket approval (PMA) application to the U.S. Food and Drug
Administration (FDA) for its myChoice® HRD CDx test.
Myriad is submitting myChoice HRD as a companion diagnostic for
the identification of patients with ovarian, fallopian or primary
peritoneal cancer who have received three or more lines of therapy
and whose tumors harbor a BRCA mutation or are BRCA wild type yet
are deficient in homologous recombination DNA repair and sensitive
to their last round of platinum and could derive clinical benefit
from treatment with the poly ADP ribose (PARP) inhibitor Zejula®
(niraparib). “This submission of myChoice HRD CDx to the FDA is a
major milestone for Myriad’s companion diagnostic program in
oncology and our first indication for a tumor-based test,” said
Nicole Lambert, president, Myriad Oncology. “In clinical
studies, the myChoice HRD test effectively identified heavily
pre-treated patients with ovarian, fallopian or primary peritoneal
cancer who are likely to benefit from Zejula. We believe
myChoice HRD CDx can help inform therapy selection and potentially
improve outcomes for
patients.”
The top-line finding from the QUADRA study, which will be the
registration study used for Zejula in this indication, found that
patients in the fourth and fifth line setting who were myChoice HRD
positive and sensitive to their last platinum therapy, had a
confirmed objective response rate of 28 percent (p=0.0005), which
was highly statistically significant and a median duration of
response of 9.2 months.
About myChoice® HRD CDx Myriad's myChoice HRD
CDx is the most comprehensive homologous recombination deficiency
test, enabling physicians to identify patients with tumors that
have lost the ability to repair double-stranded DNA breaks,
resulting in increased susceptibility to DNA-damaging drugs such as
platinum drugs or PARP inhibitors. The myChoice HRD test is a
composite of three proprietary technologies (loss of
heterozygosity, telomeric allelic imbalance and large-scale state
transitions).
About Ovarian CancerOvarian cancer affects
approximately 22,000 women per year in the United States according
to the American Cancer Society. Typically, ovarian cancer is
diagnosed at later stages when it has metastasised to other areas
of the body and only 20 percent of patients are diagnosed with
early stage disease. Ovarian cancer is one of the deadliest cancers
with approximately 14,000 deaths per year attributed to the
disease. Patients with certain characteristics such as a family
history of the disease, certain genetic mutations such as those in
the BRCA1 and BRCA2 genes, obesity and endometriosis face a higher
risk from ovarian cancer.
About Zejula® (Niraparib)Zejula (niraparib) is
a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in a
complete or partial response to platinum-based chemotherapy. In
preclinical studies, Zejula concentrates in the tumor relative to
plasma, delivering greater than 90% durable inhibition of PARP 1/2
and a persistent antitumor effect. Hematologic adverse reactions
(thrombocytopenia, anemia and neutropenia), as well as
cardiovascular effects (hypertension and hypertensive crisis) have
been reported in patients treated with Zejula. Monitor complete
blood counts to detect hematologic adverse reactions, as well as to
detect cardiovascular disorders, during treatment.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML),
including some fatal cases, was reported in patients treated with
Zejula. Discontinue Zejula if MDS/AML is confirmed. Zejula
can cause fetal harm and females of reproductive potential should
use effective contraception. Please see full U.S. prescribing
information, including additional important safety information,
available at www.zejula.com. TESARO, a GlaxoSmithKline
business, is commercializing ZEJULA. ZEJULA is a registered
trademark of TESARO.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
five strategic imperatives: build upon a solid hereditary
cancer foundation, growing new product volume, expanding
reimbursement coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. For more information on how Myriad is making a
difference, please visit the Company's website:
www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP,
myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice,
myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD,
EndoPredict, Vectra, GeneSight, riskScore, Prequel, Foresight and
Prolaris are trademarks or registered trademarks of Myriad
Genetics, Inc. or its wholly owned subsidiaries in the United
States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor StatementThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements related to the first module of the company’s premarket
approval (PMA) application to the U.S. Food and Drug Administration
(FDA) for myChoice® HRD CDx; the use of myChoice HRD CDx as a
companion diagnostic to accurately identify patients with ovarian,
fallopian or primary peritoneal cancer who have received three or
more previous rounds of chemotherapy and are considering treatment
with ZEJULA; clinical studies that demonstrated the myChoice HRD
CDx test effectively identified heavily pre-treated patients with
ovarian, fallopian or primary peritoneal cancer who are likely to
benefit from Zejula; the ability of myChoice HRD CDx to inform
therapy selection and potentially improve outcomes for patients;
and the Company's strategic directives under the caption "About
Myriad Genetics." These "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 forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our molecular diagnostic tests and
pharmaceutical and clinical services may decline; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in governmental or private insurers’
reimbursement levels for our tests or our ability to obtain
reimbursement for our new tests at comparable levels to our
existing tests; risks related to increased competition and the
development of new competing tests and services; the risk that we
may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and pharmaceutical and
clinical services in a timely manner, or at all; the risk that we
may not successfully develop new markets for our molecular
diagnostic tests and pharmaceutical and clinical services,
including our ability to successfully generate revenue outside the
United States; the risk that licenses to the technology underlying
our molecular diagnostic tests and pharmaceutical and clinical
services and any future tests and services are terminated or cannot
be maintained on satisfactory terms; risks related to delays or
other problems with operating our laboratory testing facilities and
our healthcare clinic; risks related to public concern over genetic
testing in general or our tests in particular; risks related to
regulatory requirements or enforcement in the United States and
foreign countries and changes in the structure of the healthcare
system or healthcare payment systems; risks related to our ability
to obtain new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; the
risk that we or our licensors may be unable to protect or that
third parties will infringe the proprietary technologies underlying
our tests; the risk of patent-infringement claims or challenges to
the validity of our patents or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical services
and patents or enforcement in the United States and foreign
countries, such as the Supreme Court decision in the lawsuit
brought against us by the Association for Molecular Pathology et
al; risks of new, changing and competitive technologies and
regulations in the United States and internationally; the risk that
we may be unable to comply with financial operating covenants under
our credit or lending agreements; the risk that we will be
unable to pay, when due, amounts due under our credit or lending
agreements; and other factors discussed under the heading "Risk
Factors" contained in Item 1A of our most recent Annual Report on
Form 10-K for the fiscal year ended June 30, 2018, which has been
filed with the Securities and Exchange Commission, as well as any
updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form
8-K. All information in this press release is as of the date
of the release, and Myriad undertakes no duty to update this
information unless required by law.
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Media Contact: |
Ron Rogers |
Investor Contact: |
Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
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