AstraZeneca PLC and Merck & Co., Inc. announced that the European Commission 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, 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. LYNPARZA also demonstrated a statistically significant and clinically meaningful improvement inoverall survival, reducing the risk of death by 32% (HR=0.68; [98.5% CI, 0.47-0.97]; p=0.009) versus placebo. The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.

The most common adverse reactions (ARs) =10% for LYNPARZA were nausea (57%), fatigue (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%) and stomatitis (10%). Approximately 10% of patients who received LYNPARZA discontinued treatment due to an AR. The most common Grade =3 ARs for LYNPARZA were anemia (9%), neutropenia (5%), leukopenia (3%) and fatigue (1.8%).

Breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. In the European Union (EU), one in seven people who were assigned female at birth will develop breast cancer in their lifetime. Approximately 90% of breast cancer patients worldwide are diagnosed with early breast cancer; however, a quarter of these patients will experience disease recurrence following surgery.

In Europe, germline BRCA mutations are found in approximately 9% of patients.