January 21, 2020 -- Myriad Genetics' BRACAnalysis companion diagnostic for the drug olaparib (Lynparza) is headed for a new indication in prostate cancer, following the filing of a supplemental premarket approval application with the U.S. Food and Drug Administration (FDA).
The test detects and classifies variants of BRCA1 and BRCA2 genes in whole blood specimens. An application for Lynparza, which is a poly (ADP-ribose) polymerase inhibitor marketed by AstraZeneca and Merck, in the second-line treatment of metastatic castration-resistant prostate cancer (mCRPC) with suspected deleterious germline or somatic gene mutations has been accepted by the FDA. The filing has priority review with the agency, and a user fee date has been set for the second quarter.
Both submissions are supported by the pivotal PROfound study of olaparib versus abiraterone (Zytiga, Johnson & Johnson) or enzalutamide (Xtandi, Astellas/Pfizer) in mCRPC. In the study, men with BRCA-mutated disease who were taking Lynparza had significantly longer progression-free survival.
This is just the latest filing to come through in the partnership between Myriad and AstraZeneca. The BRACAnalysis CDx test was approved by the FDA in December as a companion diagnostic to Lynparza for patients with pancreatic cancer. It is also cleared in ovarian cancer and metastatic breast cancer.