Myriad’s BRACAnalysis CDx® Supplementary PMA Accepted by FDA for Review as a Companion Diagnostic for Lynparza® (olaparib...
October 18 2017 - 07:00AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that
the U.S. Food and Drug Administration (FDA) has accepted
its supplementary premarket approval (sPMA) application for
BRACAnalysis CDx
® to be used as a companion
diagnostic with AstraZeneca’s PARP inhibitor
Lynparza
® (olaparib) in patients with
HER2-negative metastatic breast cancer. Myriad expects the
FDA’s priority review process to conclude in the fiscal
third-quarter 2018.
Myriad’s sPMA filing follows positive results from the Phase III
OlympiAD trial, which demonstrated that Lynparza significantly
reduced the risk of disease progression or death in patients with
BRCA-mutated, HER2-negative metastatic breast cancer by 42 percent
compared to standard therapy. The results of the OlympiAD
trial were published in the New England Journal of Medicine in
June.
"The acceptance of the sPMA for BRACAnalysis CDx is a
significant step towards enabling personalized medicine for
patients with metastatic breast cancer,” said Mark C. Capone,
president and CEO, Myriad Genetics. “As the pioneer in
companion diagnostics for PARP inhibitors, we are excited to once
again partner with AstraZeneca and broaden access to Lynparza for
even more patients.”
If approved, BRACAnalysis CDx would be the first and
only FDA-approved companion diagnostic for use with a PARP
inhibitor to identify HER2-negative metastatic breast cancer
patients with a BRCA mutation who would benefit from a PARP
inhibitor. The Company estimates there are approximately
125,000 patients with metastatic breast cancer who would
immediately qualify for the BRACAnalysis CDx test, followed by
60,000 new patients per year on an ongoing basis.
The ongoing collaboration with AstraZeneca to develop a novel
companion diagnostic test to identify candidates for treatment with
olaparib began in 2007. In Dec. 2014, Myriad received FDA
approval for BRACAnalysis CDx to help identify patients with
advanced ovarian cancer who are eligible for fourth-line treatment
with olaparib. BRACAnalysis CDx is Myriad’s first
FDA-approved companion diagnostic and was the first-ever laboratory
developed test approved by the FDA.
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 ovarian
cancer patients with deleterious or suspected deleterious germline
BRCA variants eligible for fourth line treatment with Lynparza™
(olaparib). 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.
About Lynparza Lynparza (olaparib) is an
innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that may exploit tumour DNA damage response (DDR) pathway
deficiencies to preferentially kill cancer cells. Lynparza is
the foundation of AstraZeneca’s industry-leading portfolio of
compounds targeting DNA damage response (DDR) mechanisms in cancer
cells. Lynparza is currently approved by regulatory health
authorities in the EU for use as monotherapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed
BRCA-mutated (germline and/or somatic) high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
response (complete or partial) to platinum-based
chemotherapy. It also is approved in the United States 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 and for the treatment of adult patients with
deleterious or suspected deleterious germline BRCA-mutated advanced
ovarian cancer who have been treated with three or more prior lines
of chemotherapy. Select patients for therapy based on an
FDA-approved companion diagnostic for Lynparza. Lynparza is
currently being investigated in another separate non-metastatic
breast cancer Phase III study called OLYMPIA. This study is still
open and recruiting patients internationally. In July 2017,
AstraZeneca and Merck & Co., Inc., announced a global strategic
oncology collaboration to jointly develop and commercialize
AstraZeneca’s Lynparza, the world’s first and leading PARP
inhibitor.
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: maintaining leadership in an
expanding hereditary cancer market, 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra DA, GeneSight, EndoPredict 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 relating to related to the ability of the BRACAnalysis
CDx test to successfully identify metastatic breast cancer patients
with improved outcomes from olaparib; the Company’s belief that
BRACAnalysis CDx is a significant step towards enabling
personalized medicine for patients with metastatic breast cancer;
the Company’s role as a pioneer in companion diagnostics for PARP
inhibitors and ability to broaden access to Lynparza for even more
patients; the size of the patient population who can benefit from
BRCA testing; the importance of the BRACAnalysis CDx test for this
patient population and the ability to identify patients likely to
benefit from PARP inhibition therapy; the number of patients with
metastatic breast cancer who would benefit from BRCA testing if
approved as a new indication; the Company’s ongoing collaboration
with AstraZeneca to develop a novel companion diagnostic test to
identify candidates for 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 described or implied in
the forward-looking statements. These risks include, but are not
limited to: the risk that sales and profit margins of our existing
molecular diagnostic tests and pharmaceutical and clinical services
may decline or will not continue to increase at historical rates;
risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
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 tests and any future tests are terminated or
cannot be maintained on satisfactory terms; risks related to delays
or other problems with operating our laboratory testing facilities;
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, including
but not limited to our acquisition of Assurex, Sividon and the
Clinic; risks related to our projections about the potential market
opportunity for our products; 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; 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, 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.
Media Contact: Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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