FDA has granted premarket approval to Myriad Genetics Inc, Salt Lake City, for the company’s BRACAnalysis CDxtest to be used as a companion diagnostic for the poly ADP ribose polymerase (PARP) inhibitor Talzenna (talazoparib), by Pfizer Inc, New York City.

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.

Sanders

Lloyd Sanders, Myriad Oncology.

“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 ethylenediamine tetraacetic acid (EDTA). Single nucleotide variants and small insertions and deletions 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 performed only at Myriad Genetic Laboratories.

The agency’s approvals are based on results from the Embraca trial, which evaluated Talzenna versus physician’s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

Johnathan Lancaster, MD, PhD, Myriad Genetic Laboratories.

Johnathan Lancaster, MD, PhD, Myriad Genetic Laboratories.

“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 at Myriad Genetics. “It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”

Announcement of the FDA approvals came just days after Myriad and Pfizer announced agreement on a plan under which each company remains responsible for the commercialization of its respective product, but enabling the companies to collaborate on certain commercial activities intended to support the use of BRACAnalysis CDx in identifying patients for potential treatment with Talzenna.

“We believe this commercial collaboration is another strong indication of Myriad’s global leadership in the field of companion diagnostics for PARP inhibitors and personalized medicine,” says Sanders. “We are excited to be working with Pfizer and towards ensuring patients have access to this class of drugs.”

For further information, visit Myriad Genetics.

Featured image: The BRACAnalysis CDx kit by Myriad Genetics.