The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Lynparza (olaparib) for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Lynparza is sponsored by AstraZeneca and Merck.
The CHMP based its positive opinion on results from the phase III OlympiA trial presented during the 2021 American Society of Clinical Oncology annual meeting and published in The New England Journal of Medicine.
In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers, or death by 42% (HR=0.58; 99.5% CI: 0.41-0.82; p<0.0001) versus placebo.
Overall survival data showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS, reducing the risk of death by 32% (HR=0.68; 98.5% CI: 0.47-0.97; p=0.0091) compared to placebo.
The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.
In March 2022, Lynparza was approved by FDA for the adjuvant treatment of patients with gBRCAm, HER2-negative high-risk early breast cancer, based on results from the OlympiA trial. Full prescribing information can be found here.
Lynparza is also approved in the US, 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 III OlympiAD trial. In the EU and Japan, this indication also includes patients with locally advanced breast cancer.
