FDA has recently granted approval for the BRACAnalysis CDx assay by Myriad Genetics Inc, Salt Lake City, to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s poly ADP ribose polymerase inhibitor, Talzenna (talazoparib).
Talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline (inherited) BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. One in eight women are diagnosed with breast cancer in the United States, and one-third will progress to the metastatic stage of the disease.
“We congratulate Pfizer on obtaining FDA approval of Talzenna for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test,” says Lloyd Sanders, president of Myriad Oncology. “We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test.”
BRACAnalysis CDx is an in vitro diagnostic intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA). Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. The assay is for professional use only and is performed only at Myriad Genetic Laboratories in Salt Lake City.
The agency’s approvals are based on results from the Embraca trial that evaluated Talzenna versus physician’s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.
“Myriad’s BRACAnalysis CDx test was shown in the Embraca trial to accurately identify certain patients with a germline BRCA mutation who may benefit from Talzenna,” says Johnathan Lancaster, MD, PhD, chief medical officer of Myriad Genetics. “It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”
For further information, visit Myriad Genetics.
Featured image: Metastatic breast cancer cells; image by Nicola Ferrari courtesy Dreamstime.