Olaparib Gets Priority Review for BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

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The application is supported by data from the phase 3 OlympiA trial.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application for olaparib for adjuvant treatment of patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

The application is supported by data from the multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 OlympiA trial (ClinicalTrials.gov Identifier: NCT02032823) which evaluated the efficacy and safety of olaparib in 1836 patients with germline BRCAm, HER2-negative high-risk breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned 1:1 to receive either olaparib 300mg orally twice daily or placebo. 

The primary endpoint was invasive disease free survival, defined as time from randomization to date of first loco-regional or distant recurrence or new cancer or death from any cause.

Treatment with olaparib was associated with a 42% reduction in the risk of invasive breast cancer recurrence, second cancers or death compared with placebo (hazard ratio 0.58; 99.5% CI, 0.41-0.82; P <.0001). The safety profile of olaparib was consistent with that seen in previous studies. The most common adverse events reported with olaparib were nausea, fatigue, anemia, and vomiting.

The FDA is expected to complete its review of the application by the first quarter of 2022.

Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is currently marketed under the brand name Lynparza® and is approved for the treatment of prostate, ovarian, breast, and pancreatic cancer.


FDA accepts regulatory submission of supplemental New Drug Application for Lynparza® (olaparib) as adjuvant treatment in BRCA-mutated, HER2-negative high-risk early breast cancer and grants Priority Review. News release. AstraZeneca and Merck. Accessed November 30, 2021. https://www.businesswire.com/news/home/20211130005353/en/FDA-Accepts-Regulatory-Submission-of-Supplemental-New-Drug-Application-for-LYNPARZA%C2%AE-olaparib-as-Adjuvant-Treatment-in-BRCA-Mutated-HER2-Negative-High-Risk-Early-Breast-Cancer-and-Grants-Priority-Review