Adjuvant Olaparib Approved in European Union for BRCA1/2-Positive, HER2-Negative High-Risk Early Breast Cancer


The European Commission approved olaparib as monotherapy or in combination with endocrine therapy for patients with germline BRCA1/2-mutant, HER2-negative high-risk early breast cancer.

Olaparib (Lynparza) as monotherapy or in combination with endocrine therapy has been approved in the European Commission for adjuvant treatment of patients with germline BRCA1/2 mutations who have HER2-negative high-risk early breast cancer that was previously treated with neoadjuvant or adjuvant chemotherapy, according to a press release from AstraZeneca and Merck.1

Based on results from the phase 3 OlympiA trial (NCT02032823), the PARP inhibitor was approved by the European Medicine Agency’s Committee for Medicinal Products for Human Use.2 The trial showed a meaningful improvement in the primary end point of invasive disease-free survival, which reduced the risk of invasive breast cancer recurrences, new cancer, or death by 42% (HR, 0.58; 99.5% CI, 0.41-0.82; P <.0001) compared with the placebo. An improvement in overall survival was also observed with a reduction in the risk of death of 32% (HR, 0.68; 98.5% CI, 0.47-0.97; P = .009).

“Today’s approval marks a new era of care in Europe for patients with an inherited form of breast cancer. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Olaparib is the first PARP inhibitor to demonstrate overall survival for high-risk early-stage breast cancer patients with germline BRCA mutations and I am hopeful it will become a new standard of care,” Andrew Tutt, MD, global chair of the OlympiA trial and professor of Oncology at The Institute of Cancer Research, London and King’s College London, said in the press release.

In March 2022, the FDA approved olaparib for adjuvant use in patients with BRCA-mutated, HER2-negative high-risk early breast cancer after treatment with chemotherapy prior to or following surgery. Additionally, olaparib is approved in the United States, European Union, Japan, and various other countries for patients with germline BRCA mutations and HER2-negative metastatic breast cancer that has been previously treated with chemotherapy. If patients have hormone receptor–positive disease, they may receive endocrine therapy. For patients in the European Union, the approval also includes those with locally advanced breast cancer.


  1. Lynparza (olaparib) approved in the EU as adjuvant treatment for patients with germline BRCA-Mutated, HER2-negative high-risk early breast cancer. News Release. Merck. August 4, 2022. Accessed August 5, 2022.
  2. Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. doi:10.1056/NEJMoa2105215
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