China OKs Lynparza as Maintenance Therapy for Advanced Ovarian Cancers with BRCA Mutations

China OKs Lynparza as Maintenance Therapy for Advanced Ovarian Cancers with BRCA Mutations
Oral Lynparza (olaparib) has been approved in China as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer who responded to initial platinum-based chemotherapy, AstraZeneca and Merck (known as MSD outside the U.S. and Canada) announced. Lynparza is now the first PARP enzyme inhibitor approved in that country as an initial maintenance treatment for BRCA-mutated advanced ovarian cancer. Similar approvals have been granted in the U.S., Europe, Canada, Brazil and Japan. “This approval marks a new era for women with BRCA-mutated advanced ovarian cancer in China, where the prevalence of BRCA mutations in advanced disease is higher than the international average,” Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said in a press release. This oral anti-cancer treatment works by blocking the PARP enzyme, which is involved in DNA repair and cancer cell survival and proliferation. It has been found to be particularly effective in patients carrying genetic mutations in the BRCA genes, which also play a role in DNA repair. The approval by China's National Medical Products Administration was based on clinical data from the ongoing SOLO-1 Phase 3 trial (NCT01844986), in which Lynparza as a maintenance monotherapy reduced the risk of disease progression or death by 70% compared to a placebo. SOLO-1 enrolled 391 patients with high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer, who responded, partly or completely, to their first-line platinum-based chemotherapy. Participants, with either inherited or acquired BRCA mutations, were randomly assigned to Lynparza (260 patients) or a placebo (131 patients), given twice daily for two years or
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