FDA Approves Myriad’s myChoice® CDx Test to Help Identify Women Eligible for Treatment with Zejula® in Late-line Ovarian Cancer
First FDA Approval Advances Precision Medicine for Women with Ovarian Cancer Who have Received Three or More Previous Chemotherapy Regimens
SALT LAKE CITY, Oct. 23, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that the U.S. Food and Drug Administration (FDA) approved myChoice® CDx for use as a companion diagnostic by healthcare professionals to identify women with advanced ovarian cancer who are candidates for Zejula® (niraparib) in the late-line treatment setting.
GlaxoSmithKline also announced that it received approval from the FDA for an expanded indication for Zejula for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency. Today’s announcement marks the first FDA-approval for myChoice CDx, which is the only FDA-approved tumor test for this indication.
“We congratulate GlaxoSmithKline on its FDA approval of Zejula for women with ovarian cancer,” said Jerry Lanchbury, Ph.D., chief scientific officer of Myriad. “Today’s approval marks a historic milestone for the myChoice CDx test after more than 10 years of development and demonstrates Myriad’s commitment to pioneering science and collaboration with pharmaceutical partners in order to accelerate precision therapies for people with cancer.”
myChoice CDx is the first and only tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants with comprehensive assessment of genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.
“Women with advanced ovarian cancer who have had multiple rounds of chemotherapy have limited treatment options and today’s approval offers new hope,” said Nicole Lambert, president of Myriad Oncology. “We look forward to working with the medical community to make the myChoice CDx test widely accessible and in helping clinicians determine whether their patients are eligible for treatment with Zejula.”
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the frontline, approximately 85 percent of patients will experience disease recurrence. Once the disease recurs, it is considered incurable with time to each future recurrence getting shorter. Late-line treatment options for women with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10 percent when treated with chemotherapy.
About myChoice® CDx
myChoice CDx is an FDA-approved companion diagnostic test for use by healthcare professionals to identify women with advanced ovarian cancer who are candidates for ZEJULA in the late-line treatment setting. myChoice CDx is the first and only comprehensive tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants and assessing genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.
About Myriad Genetics
Myriad 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 HRD, 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.
ZEJULA is a registered trademark of TESARO, Inc. For full prescribing information visit www.zejula.com/hcp
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the U.S. Food and Drug Administration’s approval of myChoice® CDx as a companion diagnostic to niraparib for use in ovarian cancer patients; accelerate precision therapies for people with cancer; making the myChoice CDx test widely accessible; 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.
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