The U.S. Food and Drug Administration (FDA) has approved Myriad Genetics BRACAnalysis CDx® for use as a companion diagnostic by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor olaparib (Lynparza™; AstraZeneca/Merck*) which is designed to exploits tumor DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells.
In vitro Diagnostic test
BRACAnalysis CDx is an in vitro diagnostic device 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 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.
Results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with olaparib. Detection of deleterious or suspected deleterious germline BRCA variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from niraparib (Zejula®; Tesaro) maintenance therapy.
The new test is the first and only FDA-approved test for use in this indication.
“This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA approved test to help ensure that they will receive the best available therapy,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics.
“As shown in the OlympiAD study, Myriad’s BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from [olaparib],” Lancaster added.
The approval also adds to the body of knowledge about the clinical use and value of companion diagnostics to enable personalized medicine for people with cancer.
“We congratulate AstraZeneca and Merck on obtaining FDA approval of [olaparib] for patients with metastatic breast cancer, which is the first approval of a PARP inhibitor outside of ovarian cancer. As the pioneers in identifying likely responders to PARP inhibitors, we are excited to broaden the use of BRACAnalysis CDx as the companion diagnostic for this important new indication,” noted Mark C. Capone, president and CEO, Myriad Genetics.
“We will be actively working with all stakeholders to raise awareness so that patients can be immediately tested to determine if they are likely to benefit from [olaparib],” he said.
Approximately one in eight women are diagnosed with breast cancer in the United States, and one-third are diagnosed with or will progress to the metastatic stage of the disease.
“There are more than 155,000 patients with metastatic breast cancer in the United States, and we estimate that 125,000 do not know their BRCA status,” Lancaster said.
“This new FDA approval of BRACAnalysis CDx for patients with metastatic breast cancer significantly expands the population who can access BRCA testing and potentially benefit from PARP inhibition therapy,” he observed.
The collaboration between Myriad Genetics and AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. The new metastatic breast cancer indication is the second FDA approval of BRACAnalysis CDx for use in conjunction with olaparib.
In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.
In July 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to jointly co-develop and co-commercialize olaparib.
* Known as MSD outside of the U.S. and Canada.
Last Editorial Review: January 11, 2018
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