Myriad Gets FDA Approval for Metastatic Pancreatic Cancer Drug
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.”
