Myriad to seek further BRACAnalysis CDx FDA approval

By staff writers

August 8, 2019 -- Myriad Genetics plans to seek supplementary premarket approval from the U.S. Food and Drug Administration (FDA) for an additional application of its BRACAnalysis CDx companion diagnostic test for olaparib (Lynparza): for patients with metastatic, castration-resistant prostate cancer with germline BRCA mutations.

The move comes after the AstraZeneca/Merck phase III PROfound study showed that men with this type of prostate cancer who test positive for mutations in homologous recombination repair genes benefit from treatment with olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, the company said.

The collaboration between AstraZeneca and Merck on olaparib began in 2007 and has resulted in a number of regulatory clearances for BRACAnalysis CDx, including the following:

  • February 2019: The Japanese Ministry of Health, Labour and Welfare approved BRACAnalysis CDx to identify women with ovarian cancer who have a germline BRCA mutation and are eligible for first-line maintenance therapy with olaparib.
  • December 2018: The FDA approved BRACAnalysis CDx to identify patients newly diagnosed with advanced ovarian cancer who are eligible for first-line maintenance treatment with olaparib.
  • January 2018: The FDA approved BRACAnalysis CDx to identify patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible for treatment with olaparib.

BRACAnalysis CDx is an IVD device for the detection and classification of variants in the BRCA1 and BRCA2 genes, according to Myriad Genetics.

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