FDA Grants Priority Review to Olaparib for HER2-Negative High-Risk Breast Cancer
Posted: Tuesday, December 7, 2021
On November 30, the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application and granted Priority Review to the PARP inhibitor olaparib for the adjuvant treatment of patients with BRCA-mutated HER2-negative high-risk early breast cancer who were previously treated with chemotherapy before or after surgery. Olaparib is approved in the United States, European Union, Japan, and other countries for the treatment of patients with germline BRCA-mutated, HER2-negative, metastatic breast cancer previously treated with chemotherapy. The European Union indication is expanded also to include patients with locally advanced breast cancer.
The FDA’s decision was grounded on the multicenter phase III OlympiA trial results, which were simultaneously presented at the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. The study tested the efficacy and safety of olaparib tablets versus placebo as adjuvant treatment in patients with germline BRCA-mutated high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
The results showed that administering olaparib produced a statistically significant and clinically meaningful improvement in invasive disease–free survival, resulting in a decreased risk for invasive breast cancer recurrence. Additionally, olaparib reduced the risk of second cancers or death by 42% compared with the placebo group (P = .0001). The safety and tolerability profile of olaparib in the OlympiA trial was similar to that of other studies.
