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AstraZeneza and MSD's Lynparza (olaparib) have been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
specific information on these three approvals: patients with HRD recombinant repair defects (HRD) ovarian cancer, patients with BRCA gene mutation (BRCAm) with anti-resistance prostate cancer (mCRPC), and non-removable pancreatic cancer.
approval by Japan's Ministry of Health, Labour and Industry is based on positive results from clinical trials in PAOLA-1, PROfound, and POLO III, published in the New England Journal of Medicine.
dave Fredrickson, executive vice president of AstraZenecom's oncology division, said: "These three approvals allow Japanese patients to use Lynparza, a targeted therapy for their specific biomarkers.
helps doctors determine treatment options for individual patients to significantly delay the progression of the disease."
Lynparza (olaparib) is the first PARP inhibitor and the first targeted therapy to block DNA damage response (DDR) in cells/tumors with HRR defects such as BRCA1 and/or BRCA2 mutations.
Lynparza's inhibition of PARP causes DNA double strands to break, which in turn contributes to cancer cell death.
Lynparza is being tested in a variety of PARP-dependent tumor types.
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