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News and reporting on BRCA biomarkers.
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.
The guidelines place a stronger emphasis on pancreatic cancer risk genes, and broaden testing recommendations for those with Ashkenazi Jewish ancestry.
Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.
After reviewing more than 100 studies, the panel issued recommendations focused on women with a personal or family history of BRCA1/2-related cancers or high-risk ancestry.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The grant recipients will receive up to $5 million each and are led by scientists at institutions including Harvard Medical School and the Cleveland Clinic.