Myriad Gets FDA Approval for Metastatic Pancreatic Cancer Drug

- December 31st, 2019

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.”

Click here to read the full press release.

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