AstraZeneca and MSD Announce China Approval of New Indication for Lynparza® in Combination with Abiraterone and Prednisone/Prednisolone for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

On July 31, AstraZeneca and MSD jointly announced that the PARP inhibitorOlaparib TabletsApproved for a new indication in China, in combination with abiraterone and prednisone or prednisolone forCarrying germline or somatic BRCA mutations(gBRCAm or sBRCAm)Metastatic Castration-Resistant Prostate Cancer（mCRPC）Treatment of adult patients.

Screenshot source: Official WeChat account of the company

The approval of this new indication is based on the subgroup analysis results from the global cohort and the Chinese cohort of the PROpel Phase III trial. Data from BRCA-mutated patients in the global cohort showed that, compared to abiraterone monotherapy, the combination of olaparib and abiraterone demonstrated improvements in radiographic progression-free survival. (rPFS) ...showed highly clinically significant improvements. Although the sample size of the Chinese cohort was relatively small, which limited interpretability to a certain extent, the study data still indicated improvement, consistent with the trend observed in the global cohort.

National TeamPatients with BRCA Mutation SubgroupThe analysis results show,Olaparib Combined with Abiraterone Reduces Risk of Disease Progression or Death by 76% and Risk of Death by 70%. The median rPFS and median overall survival in the olaparib plus abiraterone group（OS）Not yet reached; the median rPFS and median OS in the abiraterone monotherapy group were 8 months and 23 months, respectively.

In the global cohort of the PROpel III phase trial, the safety and tolerability of olaparib combined with abiraterone were consistent with the known safety profiles from previous clinical trials and each individual drug.

In the Chinese cohort of patients with BRCA mutations, a consistent trend in efficacy was observed compared to the global cohort with BRCA mutations. The safety results in the Chinese cohort were consistent with those in the global cohort, with no new safety issues identified.

Olaparib is the world's first PARP inhibitor. To date, olaparib has been approved for 7 indications in China.(Specific as follows)。

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