AstraZeneca's FDA Nod Could Be Big

Health and Healthcare

Published: December 30, 2019 9:50 am

Last Updated: January 30, 2020 11:45 am

AstraZeneca PLC (NYSE: AZN) has announced that the U.S. Food and Drug Administration (FDA) has approved its companion diagnostic test that identifies patients with metastatic pancreatic cancer.

Specifically, the approval is for BRACAnalysis CDx for use as a companion diagnostic test by health care professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza (olaparib).

Currently, BRACAnalysis CDx is the first and only FDA-approved genetic test for this indication.

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% of all cases.

Ruth March, Ph.D., senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca, commented:

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. 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.

Shares of AstraZeneca were up less than 1% early on Monday, at $50.54 in a 52-week range of $35.30 to $51.23. The consensus price target is $52.92.

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