Myriad Submits sPMA for BRACAnalysis® CDx as a Companion Diagnostic for Lynparza® in Metastatic Castration-resistant Prost...
January 21 2020 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, announced today that it has
submitted a supplementary premarket approval (sPMA) application to
the U.S. Food and Drug Administration (FDA) for its BRACAnalysis®
CDx test as a companion diagnostic to AstraZeneca’s (LSE/OMX
Nordic/NYSE: AZN) and Merck’s PARP inhibitor Lynparza® (olaparib)
for men with metastatic castration-resistant prostate cancer.
“This submission represents our tenth PMA filing for
BRACAnalysis CDx in support of Lynparza and will help men with
metastatic castration-resistant prostate cancer get access to the
most advanced therapies,” said Nicole Lambert, president Myriad
Oncology. “Myriad remains highly committed to helping our
pharmaceutical partners deliver precision medicine for patients
with cancer.”
Myriad’s filing for BRACAnalysis CDx is based on the positive
clinical results from the PROfound study, which assessed the
efficacy and safety of olaparib versus abiraterone acetate or
enzalutamide in men with metastatic castration-resistant prostate
cancer who have progressed on prior treatment with new hormonal
agent treatments and have a mutation in their homologous
recombination repair (HRRm) genes. The trial met its primary
endpoint demonstrating a statistically-significant and
clinically-meaningful improvement of radiographic progression-free
survival (rPFS) among men with mutations
in BRCA1/2 or ATM who were treated
with olaparib. The trial also met a key secondary endpoint
demonstrating significant rPFS with olaparib in the overall trial
population of men with BRCA1/2, ATM, CDK12 and 11 other HRRm gene
mutations.
Every year approximately 32,000 men are diagnosed with, or
progress to, metastatic prostate cancer in the United
States.
The collaboration between Myriad and AstraZeneca began in 2007
and has resulted in multiple regulatory approvals for BRACAnalysis
CDx enabling more patients to benefit from treatment with
olaparib.
- December 2019: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients with pancreatic
cancer who are eligible for treatment with Lynparza.
- February 2019: The Japanese Ministry of
Health, Labour, and Welfare approved BRACAnalysis CDx as a
companion diagnostic to identify women with ovarian cancer who have
a germline BRCA mutation and are eligible for first-line
maintenance therapy with Lynparza.
- December 2018: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients newly diagnosed with
advanced ovarian cancer who are eligible for first-line maintenance
treatment with Lynparza.
- March 2018: The Japanese Ministry of Health,
Labour, and Welfare approved BRACAnalysis CDx as a companion
diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible for treatment
with Lynparza.
- January 2018: FDA approved BRACAnalysis CDx as
a companion diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible treatment
with Lynparza.
- August 2017: FDA approved BRACAnalysis CDx as
a complementary diagnostic to identify patients with recurrent
platinum-sensitive germline BRCAm ovarian cancer who are
eligible for maintenance treatment with Lynparza.
- Dec. 2014: FDA approved BRACAnalysis CDx as a
companion diagnostic to identify patients with advanced ovarian
cancer who are eligible for fourth-line treatment with
Lynparza.
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 precision 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 critical success factors: building 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 CDx, EndoPredict, Vectra, GeneSight, riskScore, Prolaris,
Foresight and Prequel 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 relating to men with metastatic castration-resistant
prostate cancer getting access to the most advanced therapies;
enabling more patients to benefit from treatment with olaparib; 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, 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:Ron Rogers(801) 584-3065rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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