China’s National Medical Products Administration has granted marketing authorization for olaparib (Lynparza) as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA
-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response (PR) to frontline platinum-based chemotherapy.1
The approval is based on findings from the phase III SOLO-1 trial, in which the PARP inhibitor led to a 70% reduction in the risk of disease progression or death compared with placebo in this patient population (HR, 0.30; 95% CI, 0.23-0.41; P
The 3-year progression-free survival (PFS) rates were 60% and 27% for those who received olaparib and placebo, respectively.
“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, which co-develops olaparib with Merck (MSD), stated in a press release. “Currently, 70% of women relapse within three years of initial treatment, representing the highest reoccurrence rate among gynecological cancers worldwide. The progression-free survival benefit of Lynparza observed in SOLO-1 is a significant step towards helping these women achieve long-term remission.”
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