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The for the adjuvant treatment of early, high-risk breast cancer in patients with germline BRCA-mutations.

The drug is specifically indicated for patients with HER2-negative disease who have already been treated with neoadjuvant or adjuvant chemotherapy, according to the agency. Olaparib is the first targeted adjuvant therapy approved for this indication, according to drugmaker AstraZeneca. Approval was based on results from the phase III OlympiA trial.

"Today's approval of olaparib is great news for patients with a specific inherited form of breast cancer," said Andrew Tutt, MBChB, PhD, of the Institute of Cancer Research and Kings College London, who was global chair of the , in a . "Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed. OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients."

OlympiA enrolled 1,836 patients who had already received at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes, or both. Patients were randomized to either 1 year of olaparib 300 mg orally twice daily or placebo.

Patients receiving the PARP inhibitor had a 42% reduction in the risk of invasive disease-free survival (DFS) compared with patients receiving placebo (HR 0.58, 95% CI 0.46-0.74, P<0.0001). The 3-year invasive DFS rate was 86% (95% CI 82.8-88.4) for patients receiving olaparib versus 77% (95% CI 73.7-80.1) for those receiving placebo.

Updated results from the trial, which will be presented this week during a European Society for Medical Oncology virtual plenary, show a statistically significant and clinically meaningful improvement in overall survival with olaparib, reducing the risk of death by 32% versus placebo (HR 0.68, 95% CI 0.50-0.91, P=0.0091).

The most common adverse reactions (≥10%) in the OlympiA study were nausea, fatigue, anemia, vomiting, headache, diarrhea, leukopenia, neutropenia, decreased appetite, dysgeusia, dizziness, and stomatitis.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food for up to 1 year. Patients must be selected for therapy based on an FDA-approved diagnostic, such as BRACAnalysis CDx.

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