Findings from three Phase III clinical trials suggest that PARP inhibitors may prolong disease-free survival in some advanced ovarian cancer patients without BRCA1/2 mutations.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
Keytruda and Ibrance demonstrate activity in molecularly defined populations, while a new cohort will explore Gilotrif in tumors with NRG1 fusions.
Olaparib maintenance therapy stretched out progression-free survival, suggesting a need for germline BRCA1/2 mutation testing in pancreatic cancer patients.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.
Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.