AstraZeneca and MSD's PARP Inhibitor Olaparib Submits New NDA in China for Adjuvant Treatment of gBRCAm, HER2-Negative High-Risk Early Breast Cancer

Intelligent Finance APP learned on January 9 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that a new indication application for Olaparib Tablets has been accepted. Public information shows that Olaparib (olaparib) is jointly developed by AstraZeneca (AZN.US) and Merck & Co., Inc. (MRK.US).PARP Inhibitor, the indication for which it has applied for marketing approval this time is：Olaparib alone or in combination with endocrine therapy for patients previously treated with neoadjuvant or adjuvant chemotherapyGermline BRCA1/2 Mutation in HER2-Negative Early High-Risk Breast CancerAdjuvant Treatment for Adult Patients.

Olaparib is a "first-in-class" PARP inhibitor, as well as a targeted therapy that blocks the DNA damage repair pathway (DDR) in cells/tumors with homologous recombination repair (HRR) defects, such as BRCA1/BRCA2 mutations or defects caused by other drugs (e.g., new hormone agents).Inhibition of PARP with olaparib leads to the trapping of PARP bound to DNA single-strand breaks, replication fork stalling, collapse, and the generation of DNA double-strand breaks, resulting in cancer cell death.。

The study results showed that, in the key secondary endpoint of overall survival (OS), compared with placebo,Olaparib reduced the risk of death by 32%Olaparib increased the three-year survival rate to 92.8%, compared to 89.1% in the placebo group. Among patients treated with olaparib, 89.8% survived four years, versus 86.4% in the placebo group. Based on these study results, olaparib was approved by the U.S. FDA in March 2022 as an adjuvant therapy for patients who have received chemotherapy before or after surgery.gBRCAm HER2-negative high-risk early breast cancerPatient.