Lynparza approved in Japan for three cancers indications
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers, the UK’s AstraZeneca (LSE: AZN) and Merck & Co (NYSE: MRK) which is known as MSD outside the USA and Canada, announced on Monday.
The three approvals authorize Lynparza for: maintenance treatment after first-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 concurrent approvals by the Japanese Ministry of Health, Labor and Welfare (MHLW) 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.
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