Myriad Receives FDA Approval of BRACAnalysis CDx® as a Companion Diagnostic for Lynparza® in HRR-mutated Metastatic Castration-Resistant Prostate Cancer
SALT LAKE CITY, May 20, 2020 (GLOBE NEWSWIRE) — 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 Cancer Prostate 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 Genetics Myriad 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 Statement This 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.
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