LYNPARZA (olaparib) get three new approvals in Japan

AstraZeneca and Merck, known as MSD outside the US and Canada announced that LYNPARZA has been approved in Japan for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer. The three approvals authorise LYNPARZA for use as maintenance treatment after first-line chemotherapy containing bevacizumab (genetical recombination) in patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC); and maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.

The concurrent approvals by the Japanese Ministry of Health, Labor, and Welfare are based on results from the PAOLA-1, PROfound and POLO Phase 3 trials, which each were published in The New England Journal of Medicine.

Dave Fredrickson, Executive VP, Oncology Business Unit, AstraZeneca, said, “These three approvals allow patients in Japan to be treated with LYNPARZA, a targeted treatment personalised to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to their individual patients to substantially delay disease progression.”

Dr Roy Baynes, Senior VP and Head of Global Clinical Development, Chief Medical Officer, Merck 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.”

AstraZeneca and Merck are exploring additional trials in advanced prostate cancers including the ongoing PROpel Phase 3 trial testing LYNPARZA as a first-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021. Outside the collaboration, Merck is exploring additional trials in advanced ovarian cancer including the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA in combination with chemotherapy, followed by maintenance LYNPARZA, for the first-line treatment of women with BRCA non-mutated advanced ovarian cancer.