At the beginning of March, the Food and Drug Administration (FDA) approved Olaparib (Lynfarza) for the treatment of HER2 negative high-risk breast cancer patients with BRCA mutated germline, who have been treated with chemotherapy, before or after surgery.

The approval is supported by results from a clinical trial in which 1,836 breast cancer patients meeting the abovementioned criteria, were randomized to receive Olaparive once a day for a year, or placebo.

At three years follow-up, the probability of disease recurrence was significantly lower for patients receiving Olaparib, compared to those receiving placebo (14% versus 23%). Mortality rate, as well, was significantly lower for those receiving Olaparib, compared to those receiving placebo (8% versus 12%).

Regarding safety, Olaparib had limited effects on global patient-reported quality of life, with no serious or life-threatening adverse events.

The approval of Olaparib for the treatment of HER2 negative high-risk breast cancer patients with BRCA mutated germline, may meaningfully reduce recurrence risk and prevent progression to metastatic disease among these patients.