Japan Approves Lynparza for the Treatment of Advanced Cancers
AstraZeneca and MSD’s Lynparza (olaparib) announced on December 28, 2020, have been approved in Japan to treat advanced ovarian, prostate, and pancreatic cancers.
The three approvals authorize Lynparza for: maintenance treatment after 1st-line chemotherapy containing bevacizumab (genetical recombination) for patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer with distant metastasis (mCRPC); and as maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
The Japanese Ministry of Health, Labour, and Welfare's concurrent approvals are based on positive results from the PAOLA-1, PROfound, and POLO Phase III trials, which each were published in The New England Journal of Medicine.
Roy Baynes, SVP and Chief Medical Officer, MSD Research Laboratories, said: “For patients in Japan diagnosed with each of these types of cancer, there are very few treatment options. Approvals for treatments such as Lynparza, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalized medicine and change how these cancers are treated.”