Lynparza (olaparib), a PARP inhibitor, was granted approval by the Food and Drug Administration (FDA) for the treatment of patients with BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy. Also, patients who have HR-positive disease should have prior endocrine therapy or they would not be considered appropriate for such treatment.
This approval is based on results from the phase 3 OlympiAD trial, which showed that Lynparza reduced the risk of disease progression or death by 42 percent and improved progression-free survival (PFS) by 2.8 months versus standard chemotherapy in previously treated patients with BRCA-positive, HER2-negative breast cancer.
Treatment selection for Lynparza is based on the BRACAnalysis CDx genetic test, which today had its FDA approval expanded to include the detection of BRCA mutations in patients with breast cancer.
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