AstraZeneca and Merck announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

This approval by the EC was based on results from the Phase 3 OlympiA trial and follows the recommendation for approval of LYNPARZA in this setting by the European Medicine Agency’s Committee for Medicinal Products for Human Use. The results were published in The New England Journal of Medicinein June 2021. In OlympiA, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% (HR=0.58; [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo.

Professor Andrew Tutt, global chair of the OlympiA trial and professor of oncology, The Institute of Cancer Research, London and King’s College London, said, “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.”

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “With this approval, LYNPARZAis now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. We can now bring the benefits of LYNPARZA to this earlier setting, to help reduce the risk of life-threatening recurrence.”

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “Today’s approval offers patients with germline BRCA-mutated, HER2-negative early-stage breast cancer a new, much-needed treatment option. LYNPARZAas adjuvant treatment can significantly reduce the risk of disease recurrence and death, reinforcing the importance of conducting germline BRCA testing as soon as possible after diagnosis.”

In March 2022, LYNPARZAwas approved in the U.S. for the adjuvant treatment of patients with gBRCAm, HER2-negative high-risk early breast cancer based on results from the OlympiA trial. LYNPARZAis also approved in the U.S., EU, Japan and several other countries for the treatment of adult patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy and, if hormone receptor-positive, endocrine therapy if appropriate based on results from the Phase 3 OlympiAD trial. In the EU, this indication also includes patients with locally advanced breast cancer.