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FDA Approves Myriad Genetics' BRACAnalysis CDx With Lynparza in Earlier Ovarian Cancer Setting

NEW YORK (GenomeWeb) – The US Food and Drug Administration has expanded the indication for Myriad Genetics’ BRACAnalysis CDx, allowing it to be used to identify advanced ovarian cancer patients who are eligible to receive AstraZeneca’s Lynparza (olaparib) as first-line maintenance therapy after responding to platinum-based chemotherapy.

BRACAnalysis CDx identifies germline mutations in BRCA1 and BRCA2 genes, and predicts benefit with Lynparza, which the FDA also approved simultaneously for this additional indication in advanced ovarian cancer. The test was first approved as a companion diagnostic with Lynparza in 2014 as a tool to identify patients with advanced ovarian cancer who should receive fourth-line treatment with the PARP inhibitor. It was then approved in 2017 as a complementary diagnostic to identify patients with ovarian cancer who are eligible for second-line treatment.

Earlier this year, the FDA approved BRACAnalysis CDx for identifying eligible metastatic breast cancer patients for second-line treatment with Lynparza. Then, in March, the Japanese Ministry of Health, Labor, and Welfare approved the test for the same indication.

For the latest approval of this drug and test, the FDA evaluated data from the Phase III SOLO-1 trial, which involved 391 patients with BRCA1/2 mutations, high-grade serous or endometrioid ovarian cancer, who had complete or partial responses to chemotherapy upon entering the study, and were randomized to Lynparza or placebo for two years. Median PFS for patients on placebo was 13.8 months, and while those receiving Lynparza in the first-line setting hadn't reached the median of this endpoint at the time of data analysis, researchers estimated that Lynparza-treated patients could have median progression-free survival that's three years longer than the placebo group.

The study results were presented at a recent international cancer conference, and in a study in The New England Journal of Medicine, researchers estimated that Lynparza maintenance therapy reduced the risk of disease progression or death by 70 percent.

"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," Lloyd Sanders, president of Myriad Oncology, said in a statement.