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A Myriad Genetics-funded team found that an 86-SNV polygenic score could modify breast cancer risk in women with pathogenic mutations in cancer risk genes.
With studies showing BRCA-mutated patients have a greater magnitude of benefit, oncologists grapple with complex treatment decisions in BRCA mutation-free cases.
Breast cancer risk in carriers of pathogenic CHEK2 variants may be classified as low, moderate, or high by adding in polygenic risk score and family history data.
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 survival data from the Phase III SOLO2 trial confirms to experts that olaparib should be the standard of care maintenance therapy for patients in this setting.
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.
Additional analyses found the talazoparib arm reported a better quality of life and a limited effect of broader tumor genomic markers on clinical benefit or progression-free survival.
The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
The large BRCA1 deletion, which was not captured by initial genetic testing, might be the reason for the patient's exceptional response to a PARP inhibitor.