TGA approves Zejula for ovarian cancer providing another option for newly diagnosed women with this deadly disease

• A treatment, called ZEJULA, gives women with advanced ovarian cancer who respond to platinum-based chemotherapy, a new treatment option. ZEJULA is a type of medicine called a PARP inhibitor¹
• For newly diagnosed women with ovarian cancer, access to PARP inhibitors is currently determined by genetics and the presence of a BRCA mutation – which only ~25% of women with advanced ovarian cancer will have^2,3

• In Australia there is a significant need for more ovarian cancer treatment options – the 5-year survival rate is currently half that of breast cancer⁴

• Ovarian cancer affects around 1,500 Australian women every year, and from the 4 women diagnosed every day – 3 will unfortunately die⁴

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.

- ENDS -

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References
<sub>1. ZEJULA Consumer Medicine Information. Available online: gsk.com.au/zejula. Accessed December 2021
2. Olaparib Consumer Medicine Information. Available online: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02547-1&d=20211123172310101. Accessed November 2021.
3. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D'Andrea AD. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov. 2015;5(11):1137-54.
4. Ovarian Cancer Australia. The Statistics. Available online: https://www.ovariancancer.net.au/page/152/the-statistics#:~:text=In%20Australia%20the%20overall%20five,with%20ovarian%20cancer%20is%2046%25. Accessed November 2021.
5. Ovarian Cancer Research Foundation. Facts About Ovarian Cancer. Available online: Ovarian Cancer Research Foundation - Facts about Ovarian Cancer (ocrf.com.au). Accessed December 2021</sub>

About Zejula
Zejula is indicated for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy

Safety Information
Please talk to your doctor if you have any questions about your specific situation. The following common side effects may occur when taking ZEJULA; tiredness, weakness, stomach pain, vomiting, constipation, diarrhoea, indigestion, decreased appetite, inability to sleep, headache, dizziness, runny nose, shortness of breath, cough, high blood pressure, urinary tract infection, heart palpitations, back pain and joint pain.

About GSK  
GSK is a science-led global healthcare company with a special purpose to improve the quality of human life by helping people do more, feel better and live longer. In Australia, we offer a broad portfolio of innovative and established vaccines and medicines in respiratory disease and oncology.

Since the coronavirus pandemic began, we have been seeking ways to harness our scientific expertise and technology to make a difference. As a result, we are working with several partners to develop potential COVID-19 vaccines and treatments as quickly and safely as possible.

Here in Australia we work closely with leading local researchers and clinicians to help ensure that Australian patients can access the latest global innovations. For further information please visit www.gsk.com/about-us. 

Minimum Product Information

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. The Product Information can be accessed at www.gsk.com.au/zejula or by calling medical information on 1800 033 109.

Zejula® (Niraparib) Minimum Product Information (▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.)

Indications: ZEJULA is indicated for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy and as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Excipients include; lactose monohydrate and tartrazine (For the full list of excipients, see PI). Breast-feeding is contraindicated during administration and for 1 month after receiving the last dose. Dosage and Administration (Adults): Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. First-line ovarian cancer maintenance treatment: The recommended starting dose of niraparib is 200 mg (two 100mg capsules)  taken once daily. For patients who weigh ≥ 77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dose of niraparib is 300 mg (three 100mg capsules) taken orally once daily. Recurrent ovarian cancer maintenance treatment: The recommended starting dose is 300 mg (three x 100 mg capsules) taken orally once daily. Treatment may be interrupted to manage adverse reactions and dose reduction can be considered, see full PI. It is recommended that treatment should be continued until disease progression or unacceptable toxicity. Precautions: Haematological toxicity is common. Testing complete blood counts weekly for the first month, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended during treatment. If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, ZEJULA should be discontinued. Due to the risk of thrombocytopenia anticoagulants, and medicinal products known to reduce the thrombocyte count, should be used with caution. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients (15 out of 1785 patients or 0.84% in clinical trials). If MDS and/or AML are confirmed while on treatment, it is recommended that ZEJULA be discontinued. Hypertension, including hypertensive crisis, has been reported. Pre-existing hypertension should be adequately controlled before starting treatment. Blood pressure and heart rate should be monitored at least weekly for the first two months, then monthly for the first year and periodically thereafter during treatment. ZEJULA should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. There have been rare reports (0.09% of clinical trial patients) of niraparib-treated patients developing signs and symptoms that are consistent with Posterior Reversible Encephalopathy Syndrome (PRES). ZEJULA should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of ZEJULA. A pregnancy test should be performed on all women of childbearing potential prior to treatment. ZEJULA should be used with caution in patients >75 years of age, and those with severe renal and hepatic impairment. The safety and efficacy in children and adolescents below 18 years of age have not yet been established. No data are available. Patients may experience asthenia, fatigue and dizziness, patients who experience these symptoms should observe caution when driving or using machines. Interactions: The data in combination with cytotoxic medicinal products are limited. Therefore, caution should be taken if used in combination with vaccines, immunosuppressant agents or with other cytotoxic medicinal products. ZEJULA is a substrate for and/or inhibits Carboxylesterases, UDP-glucuronosyltransferases, a number of CYPs, efflux transporters, hepatic uptake transporters and renal uptake transporters. For more information  on pharmacokinetic interactions see full PI. Adverse reactions: Very common (≥10%): nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, leukopenia, nasopharyngitis, diarrhoea, dyspepsia dyspnoea, hypertension, back pain, dizziness, cough, urinary tract infection, arthralgia and palpitations. Common (≥1% to <10%): bronchitis, conjunctivitis, neutropenic infection, anxiety, depression, dysgeusia, tachycardia, hypokalemia, epistaxis, dry mouth, mucositis, stomatitis, photosensitivity, rash, myalgia, peripheral oedema, weight loss, increased GGT, AST, ALT, ALKP, creatinine. For other adverse reactions, see PI (Zejula Australian PI, version 3.0, 22^nd Nov 2021). 

PBS Information: Niraparib is not listed on the PBS

For product information please contact GlaxoSmithKline Australia Pty Ltd. 3/436 Johnston St, Abbotsford VIC 3067. ABN 47 100 162 481. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK or Medical Information on 1800 033 109. ZEJULA (niraparib) Trademarks are owned by or licensed to the GSK group of companies © 2021 GSK group of companies or its licensor. Date of approval: December 2021. NP-AU-NRP-PRSR-210001.