FDA Approves Diagnostic Tool for BRCA-Mutant Ovarian Cancer

The Food and Drug Administration (FDA) approved BRACAnalysis CDx to be used to identify patients with advanced ovarian cancer who have germline BRCA mutations and are eligible for first line treatment with Lynparza (olaparib) after responding to platinum-based chemotherapy, according to Myriad Genetics, the manufacturer of the companion diagnostic test.

Data from the phase 3 SOLO-1 trial, which showed that Lynparza was an efficacious maintenance treatment for patients with advanced-stage, BRCA-mutant ovarian cancer who experienced either a partial or complete response after standard platinum-based chemotherapy. Trial participants on the Lynparza arm saw a 70 percent decreased risk of disease progression or death.

In the same trial, the BRACAnalysis CDx was used to identify the patients who could benefit with Lynparza treatment.

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCA(-mutant), advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” Lloyd Sanders, president of Myriad Oncology, said in a statement. “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”

BRACAnalysis CDx is an in vitro diagnostic device that uses blood samples to detect any alterations in the BRCA1 and BRCA2 genes.

“The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options,” said Jonathan Lancaster, M.D., Ph.D., a gynecologic oncologist and chief medical officer at Myriad Genetics.