Myriad Receives FDA Approval of BRACAnalysis CDx® as a Companion Diagnostic for Lynparza® in HRR-mutated Metastatic Castrat...
May 20 2020 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, today announced that
the U.S. Food and Drug Administration (FDA) approved the
BRACAnalysis CDx® test for use as a companion diagnostic by
healthcare professionals to identify men with metastatic
castration-resistant prostate cancer (mCRPC) who are eligible for
treatment with Lynparza® (olaparib). Lynparza is approved for the
treatment of adult patients with deleterious or suspected
deleterious germline or somatic homologous recombination repair
(HRR) gene-mutated metastatic castration-resistant prostate cancer
(mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Lynparza is a novel PARP inhibitor
jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE:
AZN) and Merck, known as MSD outside of the U.S. and Canada.
“This approval is our seventh regulatory approval for
BRACAnalysis CDx in support of Lynparza and further demonstrates
our commitment to improve the lives of patients with cancer,” said
Nicole Lambert, president Myriad Oncology and Women’s Health.
“The BRACAnalysis CDx test provides clinicians with the vital
information needed to quickly match patients with an appropriate
treatment option.”
BRACAnalysis CDx is the only FDA-approved germline test to
identify men with BRCA1 and BRCA2 mutations, a subpopulation
of HRR gene mutations. In the PROfound trial, patients with
metastatic castration-resistant prostate cancer who have HRR gene
mutations had a statistically-significant and clinically meaningful
improvement of radiographic progression-free survival when treated
with Lynparza versus abiraterone acetate or enzalutamide.
“Studies have demonstrated that PARP inhibitors are highly
effective in men with BRCA1/BRCA2 mutations, in addition
to other mutations in HRR pathways. Once we identify who
these men are, they will have more options for treatment,” said
Todd Cohen, M.D., board-certified urologist and vice president of
Medical Affairs for Myriad Urology. “NCCN guidelines
recommend that men with metastatic castration-resistant prostate
cancer undergo genetic testing alongside an assessment of HRR gene
mutations in the tumor.”
The collaboration between Myriad and AstraZeneca began in 2007
and has resulted in eight regulatory approvals for BRACAnalysis CDx
and myChoice CDx enabling more patients to benefit from treatment
with olaparib.
About Metastatic Castration-Resistant Prostate
CancerProstate cancer is the second-most common cancer in
men and is associated with a significant mortality rate. In
men with mCRPC, their prostate cancer grows and spreads to other
parts of the body despite the use of androgen-deprivation therapy
to block the action of male sex hormones. An estimated 20 to
30 percent of men with advanced prostate cancer will develop CRPC
within five years, and at least 84 percent of these men will have
metastases at the time of CRPC diagnosis. Of men with no
metastases at CRPC diagnosis, 33 percent are likely to develop
metastases within two years. Despite advances in treatment for
men with mCRPC, five-year survival is low and extending survival
remains a key goal for treating these men.
About BRACAnalysis CDx®BRACAnalysis CDx is an
in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and
intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic
DNA obtained from whole blood specimens collected in EDTA.
Single nucleotide variants and small insertions and deletions
(indels) are identified by polymerase chain reaction (PCR) and
Sanger sequencing. Large deletions and duplications in BRCA1
and BRCA2 are detected using multiplex PCR. Results of the
test are used as an aid in identifying cancer patients with
deleterious or suspected deleterious germline BRCA variants, who
are or may become eligible for treatment with
Lynparza® (olaparib). Detection of deleterious or
suspected deleterious germline BRCA1 and BRCA2 variants by the
BRACAnalysis CDx test in ovarian cancer patients is also associated
with enhanced progression-free survival (PFS) from Zejula™
(niraparib) maintenance therapy. This assay is for professional use
only and is to be performed only at Myriad Genetic Laboratories, a
single laboratory site located at 320 Wakara Way, Salt Lake City,
UT 84108. Learn more at www.bracanalysiscdx.com.
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
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. 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 CDx, Vectra, Prequel, Foresight, GeneSight, riskScore 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.Lynparza is a
registered trademark of AstraZeneca.
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 men identified with BRCA1/BRCA2 mutations
having more options for treatment; 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: uncertainties associated with
COVID-19, including its possible effects on our operations and the
demand for our products and services; our ability to efficiently
and flexibly manage our business amid uncertainties related to
COVID-19; 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
decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566
U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics,
Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573
U.S. 208 (2014); 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, 2019, 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.
Media Contact:
Jared Maxwell |
|
Investor Contact:
Scott Gleason |
(801) 505-5027 |
|
(801) 584-1143 |
jmaxwell@myriad.com |
|
sgleason@myriad.com |
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