The FDA has approved its diagnostic test to identify patients with metastatic pancreatic cancer who are candidates Lynparza treatment.
Myriad Genetics (NASDAQ:MYGN) confirmed that the US Food and Drug Administration (FDA) has approved its diagnostic test, BRACAnalysis CDx, for use to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with Lynparza (olaparib).
As quoted in the press release:
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.
“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.”