Dialog Box

TGA approval of niraparib


New ovarian cancer drug provides hope for the disease which has a 48% survival rate

Ovarian Cancer Australia welcomes the Therapeutic Goods Administration’s (TGA) registration of niraparib (marketed as Zejula) for the treatment of women with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer following completion of first-line platinum-based chemotherapy. 

CEO of Ovarian Cancer Australia Jane Hill heralded the TGA approval of niraparib as an important step forward in giving these women treatment options that may delay their cancer from returning. 

“We welcome new treatment options for women with ovarian cancer. Every day, 5 women are diagnosed with ovarian cancer and 3 will die from the disease.   

“As the disease is often only diagnosed in the advanced stages, treatment options can be limited, which is reflected in the 5-year survival rate, currently only 48% making it the deadliest of all gynaecological cancers. As a comparison, the 5-year survival rate for breast cancer is 92%.”  

Prof Linda Mileshkin, interim Director of Medical Oncology at Peter MacCallum Cancer Centre explains, “niraparib is a PARP inhibitor – a targeted tablet treatment that causes ovarian cancer cells to die, by targeting a protein called PARP which cancer cells use to repair themselves. Clinical trials have shown that giving treatment with niraparib as a ‘maintenance therapy’ after first-line chemotherapy treatment has got rid of as much of the cancer as possible, can help keep the cancer under control and delay the time until any further treatment might be needed. This means that women can remain well taking a daily tablet at home, usually with a very good quality of life."

“Up to now, only women with ovarian cancer who carry the BRCA gene mutation – about 25% of cases – were able to access treatment with maintenance PARP inhibitors after first-line chemotherapy.  The TGA approval of niraparib means that all women with advanced ovarian cancer who respond to platinum-based chemotherapy have access to try this type of treatment.”  

“Niraparib has proven to be very helpful for significant numbers of women with ovarian cancer overseas, and it is great that we will hopefully soon have more access to this treatment option for women. The use of PARP inhibitor treatment for ovarian cancer has been a major advance which is enabling many of our patients to live longer and better on an oral therapy”, said Prof Mileshkin. 

“Ovarian Cancer Australia will continue to advocate for access to affordable drugs to treat ovarian cancer, and we will be advocating for niraparib to be listed on the PBS. Women living with ovarian cancer show an enormous courage in what is a very difficult disease and they deserve equitable access to a proven treatment”, said Jane Hill, CEO of Ovarian Cancer Australia 

Women seeking more information about niraparib and their eligibility to receive the drug should speak to their treatment team. Ovarian Cancer Australia’s Helpline can provide additional support and information on 1300 660 334 Monday to Friday 9 am – 5pm (AEST). 



For more information and interview requests, please contact: 

Emma Schwarer| M: 0466 492 520  | E: emma.schwarer@ovariancancer.net.au 

18 January 2022
Category: Media Releases
Tags: niraparib, pbac, pbs, treatment,