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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
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"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. \n “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 germlin...