Wednesday, March 11, 2015

FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

In continuation of my update on Olaparib

Myriad Genetics, Inc.    announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza™ (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic for use with a novel PARP inhibitor.

No comments: