Lynparza is an advanced PARP inhibitor, used for treating advanced ovarian cancer and metastatic breast cancer

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Image: Lynparza is jointly developed and marketed by AstraZeneca and MSD. Photo: Courtesy of AstraZeneca.

AstraZeneca and MSD (also called Merck & Co. in the US and Canada) have secured China’s National Medical Products Administration (NMPA) marketing authorisation of Lynparza (olaparib) for treating ovarian cancer.

NMPA approved the drug as a first-line treatment of advanced germline or somatic BRCA mutated epithelial ovarian, fallopian tube or primary peritoneal cancer in adult patients, who are in response to first-line platinum-based chemotherapy.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “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.

“Currently, 70% of women relapse within three years of initial treatment, representing the highest reoccurrence rate among gynaecological 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.”

Regulatory approval of Lynparza is based on the results from SOLO-1 trial

Jointly developed and marketed by AstraZeneca and MSD, Lynparza is an advanced PARP inhibitor used for treating advanced ovarian cancer and metastatic breast cancer.

The drug works by blocking the DNA damage response (DDR) in tumours cells, concealing a deficiency in homologous recombination repair (HRR), including mutations.

AstraZeneca said that the Chinese regulatory approval is based on the results from the SOLO-1 trial, a Phase III, randomised, double-blinded, placebo-controlled, multi-centre trial.

SOLO-1 study evaluated the efficacy and safety of Lynparza tablets (300mg) as a monotherapy, compared to placebo in patients with BRCAm advanced ovarian cancer.

According to the study results, Lynparza has reduced the risk of disease progression or death compared to placebo in women with advanced ovarian cancer.

Furthermore, Phase III PAOLA-1 trial of Lynparza in combination with bevacizumab as a treatment for women with advanced ovarian cancer also showed positive results.

MSD Research Laboratories senior vice president and global clinical development head Roy Baynes said: “Today’s approval of Lynparza reinforces the importance of patients knowing their BRCA mutation status at diagnosis.

“We are proud to provide a new option for the treatment of this devastating disease in China, and we will continue to collaborate with the Chinese government and healthcare organisations to provide Lynparza to patients who need it as quickly as possible.”