The FDA has approved Myriad Genetics’ BRACAnalysis CDx test as a companion diagnostic for the latest indication of Lynparza (olaparib) authorized by the agency. The poly ADP-ribose polymerase (PARP) inhibitor, which is co-marketed by AstraZeneca and Merck & Co., has won additional approval as a maintenance treatment for adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
According to Myriad, BRACAnalysis CDx is the first and only genetic test approved by the FDA as a companion diagnostic designed to help healthcare professionals identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with Lynparza.
The CDx approval is the seventh received by Myriad since it began collaborating with AstraZeneca in 2007.
“The approval of the BRACAnalysis CDx test for patients with pancreatic cancer highlights our shared vision and long-standing collaboration with Myriad to advance precision medicine for patients in need of new treatments,” Ruth March, Ph.D., senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca, said in a statement.
Nicole Lambert, president of Myriad Oncology, noted in a company statement that in February 2019, the National Comprehensive Cancer Network (NCCN) updated its oncology guidelines to recommend universal germline BRCA testing for all people with pancreatic cancer.
“The new FDA approval and recently updated NCCN guidelines support physicians who order testing at the time of diagnosis. The sooner we can identify patients with germline BRCA mutations, the better chance they will have to benefit from precision therapies,” Lambert stated.
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.
Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula (niraparib) maintenance therapy. BRCAnalysis CDx is for professional use only and can only be performed at Myriad Genetic Laboratories, a single lab site located in Salt Lake City.
In February 2019, Japan’s Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify women with ovarian cancer who have a germline BRCA mutation and are eligible for first-line maintenance therapy with Lynparza. It was Myriad’s second approval for BRACAnalysis CDx in Japan; the first came in March 2018, when the companion diagnostic was authorized for identifyingh patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible for treatment with Lynparza.
In the U.S., BRACAnalysis CDx was approved in December 2018 as a companion diagnostic for patients newly diagnosed with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza. BRACAnalysis CDx received earlier FDA approvals:
- In January 2018 as a companion diagnostic to identify patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible for treatment with Lynparza;
- In August 2017 as a complementary diagnostic to identify patients with recurrent platinum-sensitive germline BRCAm ovarian cancer who are eligible for maintenance treatment with Lynparza.
- In December 2014 as a companion diagnostic to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with Lynparza.
