Lynparza Approved in Japan as First-Line Maintenance Therapy for Advanced OC

Lynparza Approved in Japan as First-Line Maintenance Therapy for Advanced OC
Lynparza (olaparib) has been approved in Japan as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer that is responding, partially or completely, to their initial chemotherapy, AstraZeneca and Merck (known as MSD outside the U.S. and Canada) announced. Similar approvals have previously been granted in the U.S., Europe, Canada, and Brazil. This approval, by the Japanese Ministry of Health, Labour and Welfare, was based on clinical data from the ongoing SOLO-1 Phase 3 trial (NCT01844986), in which Lynparza cut by 70% the risk of disease progression or death compared with a placebo. “Advances in understanding the role of BRCA mutations and PARP inhibition have fundamentally changed how physicians can treat this aggressive type of cancer. With the approval of this new indication, patients in Japan with BRCA-mutated advanced ovarian cancer who respond to chemotherapy will have the opportunity to benefit from Lynparza in the first-line maintenance setting,” Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a press release. SOLO-1 enrolled 391 ovarian cancer patients with high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer, and a BRCA mutation, who were responding to their first-line platinum-based chemotherapy. Participants were randomly selected to receive either Lynparza or a placebo twice daily, for two years or until their disease progressed. Those with a partial response to the therapy at two years could potentially continue treatment. SOLO-1 aimed to determine whether Lynparza was better than a placebo at extending the time women lived without their disease worsening.
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