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News and reporting on BRCA biomarkers.
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.
Amid rapid adoption of multi-gene panels, ACMG experts are seeing some doctors and patients taking actions they shouldn't.
Absent sufficient evidence to support genetic testing for all patients, the group recommended following existing guidelines, which are based on clinical factors.