Myriad Will Seek FDA Approval of BRACAnalysis CDx? As a Companion Diagnostic for Lynparza (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
SALT LAKE CITY, Aug. 07, 2019 (GLOBE NEWSWIRE) --?Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, today announced that the AstraZeneca/Merck Phase III PROfound study (NCT02987543) demonstrated that men with metastatic castration-resistant prostate (mCRPC) cancer who tested positive for germline and somatic mutations in homologous recombination repair genes benefitted from treatment with Lynparza??(olaparib), a novel PARP inhibitor.? Myriad will file a supplementary Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC patients with germline BRCA mutations.
?The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,? said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics.? ?This study is another example of Myriad?s commitment to help our pharmaceutical partners achieve and deliver precision medicine for people with cancer.? The topline results ? announced earlier today by AstraZeneca (LSE/STO/NYSE: AZN) and Merck ? are the first reported clinical data from the?PROfound study, which assessed the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.? The results demonstrated a statistically-significant and clinically-meaningful improvement of radiographic progression-free survival among patients who tested positive for mutations in homologous recombination repair genes and were treated with?olaparib. ?We congratulate AstraZeneca and Merck on the successful completion of the PROfound trial and look forward to expanding the population of people who can potentially benefit from testing with BRACAnalysis CDx,? said Nicole Lambert, president, Myriad Oncology.? ?Importantly, this study is another example of Myriad?s commitment to leverage our portfolio of tumor and germline tests to develop and deliver precision medicine for people with cancer.? It is estimated there are more than 170,000 men are diagnosed with prostate cancer each year. Prostate cancer is the second leading cause of death by?cancer?in men, and it is estimated that?31,620 deaths?from this disease will occur this year.? The updated 2019?National Comprehensive Cancer Network (NCCN) Guidelines??state that germline?BRCA?mutations should be tested in all newly-diagnosed men with NCCN high-risk, very high-risk, regional or metastatic prostate cancer. The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.- 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.
- December 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.
Media Contact: | Ron Rogers (801) 584-3065 rrogers@myriad.com | Investor Contact: | Scott Gleason (801) 584-1143 sgleason@myriad.com |