China clears AstraZeneca, Merck & Co.'s Lynparza as first-line maintenance for BRCA-mutated ovarian cancer

AstraZeneca and Merck & Co. announced Thursday that China's National Medical Products Administration (NMPA) approved Lynparza (olaparib) as a first-line maintenance treatment for adults with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

The companies noted that Lynparza is the only PARP inhibitor authorised in this setting in China. Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, noted "in China…the prevalence of BRCA mutations in advanced disease is higher than the international average." Meanwhile, Roy Baynes, Merck's head of global clinical development, said the approval "reinforces the importance of patients knowing their BRCA mutation status at diagnosis."

The clearance is based on results from the Phase III SOLO-1 trial, which showed that Lynparza significantly reduced the risk of disease progression or death by 70% versus placebo in women with BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. Findings also demonstrated that 60% of women receiving Lynparza remained progression-free at three years compared to 27% of those on placebo.

The drug is currently approved in 65 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. Lynparza is also authorised in the US, the EU, Japan and several other countries as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. In addition, the product is approved in 44 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy, while in the EU, the label also includes locally advanced breast cancer.

AstraZeneca and Merck are also conducting additional trials in ovarian cancer and recently announced positive results from the Phase III PAOLA-1 trial, which tested Lynparza in combination with Roche's Avastin (bevacizumab) as a first-line maintenance treatment for women with newly-diagnosed advanced ovarian cancer, regardless of their biomarker status or surgical outcome.  

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