Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for the use of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a treatment for BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC) in adults. This approval marks a significant advancement in the treatment options for prostate cancer, the most common type of cancer among men in Japan.
Phase III Study Results and Clinical Improvements
The approval was supported by a Phase III study that demonstrated clinically meaningful improvements in radiographic progression-free survival (rPFS) and overall survival (OS) within a BRCAm mCRPC subgroup. The safety profile of the treatment was consistent with previous observations, providing confidence in its therapeutic potential.
Previous Approvals and Global Reach
Lynparza has previously been cleared in Japan as a therapy for BRCAm mCRPC that has progressed following prior therapy that included a new hormonal agent (NHA). This indication is also approved in China and the European Union (EU), highlighting the drug’s global impact on the treatment of BRCA-mutated prostate cancer.-Fineline Info & Tech
