NEW YORK – AstraZeneca on Thursday said Japanese regulators have approved its PARP inhibitor Lynparza (olaparib) in combination with Janssen's Zytiga (abiraterone) and prednisone or prednisolone as a treatment for patients with BRCA1/2-mutated, castration-resistant prostate cancer with distant metastases (mCRPC).
Prostate cancer is the sixth leading cause of cancer death in Japan, and there are limited options for patients with metastatic disease.
Japan's Ministry of Health, Labor, and Welfare approved this Lynparza-based regimen after reviewing data from the Phase III PROpel trial, in which the subset of mCRPC patients with BRCA1/2 mutations treated with Lynparza-Zytiga-prednisone/prednisolone had clinically meaningful improvements in radiographic progression-free survival and overall survival compared with those who received Zytiga-prednisone/prednisolone. In the Lynparza arm, median radiographic progression-free survival and overall survival were not reached compared to median radiographic progression-free survival of 8.4 months and median overall survival of 23.6 months in the Zytiga-prednisone/prednisolone arm.
The US Food and Drug Administration has approved this same indication, as well as single-agent Lynparza as a treatment for mCRPC patients with homologous recombination repair gene mutations, including BRCA1/2 mutations, after progression on Zytiga or Pfizer's Xtandi (enzalutamide). In Japan and the EU, Lynparza, which AstraZeneca markets with Merck, is approved as a single agent for patients with BRCA1/2-mutated mCRPC.