Myriad Receives FDA Approval of BRACAnalysis CDx® as Companion Diagnostic for Lynparza® (olaparib) In Patients with Germline BRCA-mutated Metastatic Pancreatic Cancer

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[{"type":"text","content":"SALT LAKE CITY, Dec. 30, 2019 (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) has approved BRACAnalysis CDx® for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza® (olaparib). Lynparza is marketed by AstraZeneca (LSE/OMX Nordic/NYSE: AZN) and Merck, known as MSD outside of the U.S. and Canada. BRACAnalysis CDx is the first and only FDA-approved genetic test for this indication.\n “The approval of the BRACAnalysis CDx test for patients with pancreatic cancer highlights our shared vision and long-standing collaboration with Myriad to advance precision medicine for patients in need of new treatments,” said Ruth March, Ph.D., senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca. “Patients with metastatic pancreatic cancer who test positive for germline-BRCA mutations can now access Lynparza, which is the first and only PARP inhibitor approved for this devastating disease.” Pancreatic cancer is the third most common cause of cancer-related death in the United States, and germline BRCA-mutated pancreatic cancer accounts for 6.2 percent of all cases. In February 2019, the National Comprehensive Cancer Network (NCCN) updated its oncology guidelines to recommend universal germline BRCA testing for all people with pancreatic cancer. “We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for people with metastatic pancreatic cancer, and we are excited to expand the use of BRACAnalysis CDx as a companion diagnostic test,” said Nicole Lambert, president of Myriad Oncology. “The new FDA approval and recently updated NCCN guidelines support physicians who order testing at the time of diagnosis. The sooner we can identify patients with germline BRCA mutations, the better chance they will have to benefit from precision therapies.” 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...

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