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News and reporting on BRCA biomarkers.
The nationwide study will enroll prostate cancer patients who do and don't meet current guidelines and assess how access to genetic information impacts their care.
An analysis of societal and health system cost-effectiveness and outcomes points to the benefits of expanding pathogenic BRCA1/2 variant testing in six countries.
The framework is meant to guide healthcare providers in facilitating prostate cancer genetic testing in a timely and responsible way, the researchers said.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.