You are here
BRACAnalysis CDx® Approved by U.S. Food and Drug Administration as Companion Diagnostic for AstraZeneca’s Lynparza® (olaparib) in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer
SALT LAKE CITY, Dec. 19, 2018 (GLOBE NEWSWIRE) -- 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 approved BRACAnalysis CDx® to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCA mutation (gBRCAm) and are eligible for first-line maintenance therapy with AstraZeneca’s PARP (poly ADP ribose polymerase) inhibitor, Lynparza® (olaparib) following response to platinum-based chemotherapy.
“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCAm advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” said Lloyd Sanders, president, Myriad Oncology. “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”
The FDA approvals are based on results from the SOLO-1 trial (ClinicalTrials.gov number: NCT01844986) that tested Lynparza tablets as a maintenance treatment for patients with, advanced-stage BRCAm ovarian cancer who experienced a complete or partial response following first-line standard platinum-based chemotherapy. The study results were published in the New England Journal of Medicine, and the key finding was that Lynparza maintenance therapy cut risk of disease progression or death by 70 percent.
“In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified patients with advanced ovarian cancer who may benefit from Lynparza,” said Johnathan Lancaster, M.D., Ph.D., gynecologic-oncologist and chief medical officer, Myriad Genetics. “The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options.”
Lynparza is being commercialized by AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada). The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.
- 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 olaparib.
- March 2018: The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
- January 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
- August 2017: FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with ovarian cancer who are eligible for second-line treatment with olaparib.
- 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 olaparib.
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. 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: http://myriadmychoice.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 five strategic imperatives: build 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 Prelude 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 the U.S. Food and Drug Administration’s approval of BRACAnalysis CDx® to be used by healthcare professionals to identify patients with advanced-stage, BRCA-mutated (BRCAm) ovarian cancer who are eligible for treatment with AstraZeneca’s PARP (poly ADP ribose polymerase) inhibitor, Lynparza® (olaparib); the indication for Lynparza for first-line maintenance therapy; the estimated number of women who are diagnosed with ovarian cancer in the United States who qualify for a BRACAnalysis CDx test; the Company’s plans to expand the use of BRACAnalysis CDx as the companion diagnostic test for Lynparza patients with advanced-stage, BRCA-mutated (BRCAm) ovarian cancer; 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, 2018, 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.