Melbourne, January 18, 2022 – GSK Australia is pleased to announce that the Therapeutic Goods Administration (TGA) has registered Zejula (niraparib) for the treatment of women with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer following completion of first-line platinum-based chemotherapy. This is currently the only PARP inhibitor approved by the TGA as a monotherapy for newly diagnosed women with advanced ovarian cancer who respond to platinum-based chemotherapy, regardless of whether or not they have a BRCA mutation.1,2
Zejula is a poly ADP-ribose polymerase inhibitor (more commonly known as a PARP inhibitor), which works by stopping proteins in our body from repairing ovarian cancer cells, causing them to die – which then helps to control the cancer.1
Ovarian cancer affects around 1,500 Australian women every year.4 Unfortunately, due to non-specific symptoms and a lack of accurate testing to identify the disease at an early stage, most women are diagnosed when ovarian cancer is advanced, meaning it can be challenging to treat and options are limited.5
“In order for women with advanced ovarian cancer to access a PARP inhibitor in Australia, their ovarian cancer must have responded to their initial chemotherapy and they need to have undergone testing to identify their BRCA mutation status” said Professor Clare Scott, Medical Oncologist, Peter MacCallum Cancer Centre. “Only about 25% of those women have the BRCA mutation that will allow them to move onto an existing PARP inhibitor – meaning 75% of women after chemotherapy are left waiting with limited treatment options.2,3 With Zejula, all women whose cancers respond to chemotherapy now have the consideration of a PARP inhibitor. A larger proportion of these women will now be able to access this therapy that may delay their cancer from getting worse.1”
“This milestone is a significant part of GSK Oncology’s commitment to providing more options to patients, and more specifically our commitment to women’s cancers,” said Patrick Desbiens, General Manager of GSK Australia & New Zealand.”
GSK are committed to bringing Zejula to Australian patients as quickly as possible and look forward
to working with stakeholders to ensure access for patients.