FDA Approves Olaparib for BRCA-Positive Breast Cancer

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Olaparib was previously granted Priority Review designation by the FDA.
Olaparib was previously granted Priority Review designation by the FDA.

The US Food and Drug Administration (FDA) expanded the indication of olaparib to include the treatment of patients with metastatic breast cancers characterized by BRCA germline mutations, according to a press release.1

Olaparib — which is also indicated for ovarian cancer — is the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer and is the first agent to be approved specifically for the treatment of breast cancer with BRCA mutations.

The FDA based its approval on data from the open-label phase 3 OlympiAD study (ClinicalTrials.gov Identifier: NCT02000622), for which researchers randomly assigned 302 patients with a germline BRCA mutation and HER2-negative metastatic breast cancer to receive olaparib 300 mg twice daily as monotherapy or investigator's choice (IC) standard single-agent therapy (capecitabine, eribulin, or vinorelbine) in 3-week cycles.

Median progression-free survival (PFS) was 7.0 months in the olaparib arm vs 4.2 months in the IC arm (hazard ratio for disease progression or death, 0.58; 95% CI, 0.43-0.80; P < .001). The response rate was 59.9% vs 28.8% among patients treated with olaparib vs IC, respectively.

The most frequently reported adverse events for olaparib included anemia, neutropenia, leukopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, dysgeusia, respiratory tract infections, nasopharyngitis, and arthralgia/myalgia.

Olaparib was previously granted Priority Review designation by the FDA.


  1. FDA approves first treatment for breast cancer with a certain inherited genetic mutation [news release]. Silver Spring, MD: US Food and Drug Administration; January 12, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592347.htm. Accessed January 12, 2018.

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