Myriad Submits sPMA for BRACAnalysis® CDx as a Companion Diagnostic for Lynparza® in Metastatic Castration-resistant Prostate Cancer
SALT LAKE CITY, Jan. 21, 2020 (GLOBE NEWSWIRE) -- 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
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 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 Statement
This 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.