Three drug approvals in Japan for AstraZeneca
In a boost for its medicines portfolio in Japan, AstraZeneca (LSE: AZN) has gained regulatory approval for not one, but three products, the Anglo-Swedish pharma major announced today.
Along with partner Merck & Co (NYSE: MRK), known as MSD outside of the USA and Canada, AstraZeneca said that Lynparza (olaparib) has been approved in Japan as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated (BRCAm) advanced ovarian cancer, as detected by an approved companion diagnostic test.
The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
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