Recently, AstraZeneca announced that the U.S. FDA has granted the PARP inhibitor olaparib (English trade name: Lynparza) Supplementary New Drug Application (sNDA) priority review qualification for the adjuvant treatment of patients with BRCA mutations. At-risk HER2-negative early breast cancer patients, these patients have already received chemotherapy neoadjuvant or adjuvant therapy.

In 2020, approximately 2.3 million women worldwide will be diagnosed with breast cancer. BRCA mutations occur in approximately 5% of breast cancer patients. Nearly 91% of breast cancer patients are still in the early stage of the disease at the time of diagnosis.

BRCA is an important protein to repair cell DNA damage, and PARP also plays an important role in repairing DNA damage. In tumor cells carrying BRCA gene mutations, the BRCA-mediated DNA damage repair pathway has been destroyed, and the use of PARP inhibitors will cause the cell to die due to excessive DNA damage that cannot be repaired. Olapali is a "first-in-class" PARP inhibitor jointly developed by AstraZeneca and MSD. It targets the DNA damage repair response (DDR) pathway and uses the "synthetic lethal" principle to kill cancer cells without affecting healthy cells.

Previously, it has been approved by the US FDA to treat advanced ovarian cancer, breast cancer, pancreatic cancer and other cancer types that carry germline BRCA mutations. At the same time, olaparib (trade name Liptrozole) is also the first new drug targeted for ovarian cancer to be approved for marketing in China. In November 2019, olaparib was again approved by the NMPA for the first-line maintenance treatment of advanced ovarian cancer patients with BRCA mutations.

This priority review qualification is awarded based on the positive results obtained in a phase 3 clinical trial. The results of clinical trials showed that compared with placebo, olaparib showed a statistically significant and clinically significant improvement in invasive disease-free survival (iDFS), recurring invasive breast cancer, new tumors or The risk of death was reduced by 42% (HR=0.58; 99.5% CI 0.41-0.82; p<0.0001). In terms of safety, the safety and tolerability characteristics of olaparib are consistent with the results observed in previous clinical trials. The trial data has been published in the "New England Journal of Medicine".