In the European Union (EU), the drug Lynparza (olaparib), developed by AstraZeneca and MSD, has been approved for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have high-risk early breast cancer that is HER2-negative and has already received neoadjuvant or adjuvant chemotherapy.
The OlympiA Phase III trial results, which were published in The New England Journal of Medicine in June 2021, served as the basis for this approval by the European Commission, which came after the Committee for Medicinal Products for Human Use of the EU recommended Lynparza be approved in this situation. 1 Based on a hazard ratio [HR] of 0.58; 99.5 percent confidence interval [CI] 0.41-0.82; p0.0001, Lynparza reduced the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo in the trial. This improvement in invasive disease-free survival (iDFS) was statistically significant and clinically significant.
Additionally, Lynparza showed a statistically significant and clinically significant improvement in overall survival (OS), lowering mortality risk versus placebo by 32% (based on an HR of 0.68; 98.5 percent CI 0.47-0.97; p=0.009). In this experiment, Lynparza’s safety and tolerability profile matched what had been seen in earlier clinical trials.
A projected 2.3 million individuals will be diagnosed with breast cancer worldwide in 2020, making it the most common malignancy.
2 Approximately 10% of HER2-negative patients in Europe have BRCA mutations, and early breast cancer accounts for about 90% of all breast cancer diagnoses worldwide.