PBS access to targeted treatment will be expanded for more Australian women with ovarian cancer

Up to 25 percent more ovarian cancer patients1 may become eligible for LYNPARZA® on the PBS

 

Eligible Australian women with newly diagnosed advanced ovarian cancer will have expanded access to a targeted treatment option, following the announcement that LYNPARZA® will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 January 2024 for an additional group of patients. LYNPARZA® is a PARP-inhibitor, which is a targeted therapy designed to destroy certain types of cancer cells.2

  • Ovarian cancer is Australia’s deadliest female cancer3, and only 49 per cent of all women diagnosed survive beyond five years.4 Approximately 2,000 Australians were diagnosed with ovarian cancer in 20224 – five women each day.
  • There is no screening program for ovarian cancer, and because symptoms can often be confused with other health conditions, many women are diagnosed with advanced disease5, when the cancer has spread and can be difficult to treat6.
  • LYNPARZA®  is already listed on the PBS as a maintenance therapy for patients with advanced Breast Cancer (BRCA)-mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • From 1 January 2024, access to LYNPARZA® (olaparib) tablets on the Pharmaceutical Benefits Scheme will be expanded for use in combination with bevacizumab (a type of cancer treatment) for maintenance therapy in eligible patients with newly diagnosed homologous recombination deficiency (HRD) positive advanced epithelial ovarian, fallopian tube or primary peritoneal cancer7, who do not carry the BRCA mutation.
  • This reimbursement represents a treatment option for patients who are HRD positive and do not carry a BRCA mutation - approximately 25 per cent of all patients diagnosed with advanced epithelial ovarian cancer1 – which is determined by genetic testing7.

From 1 January 2024, eligible patients will be able to also access a new reimbursed test to determine their eligibility to access this medicine. Known as a HRD test, this test is conducted as early as possible in a patient’s diagnosis8. The test identifies whether a woman carries a BRCA mutation, as well as HRD.9

HRD is a characteristic of some cancer cells that makes it harder for them to repair damaged DNA, increasing the risk of developing mutations, which can lead to cancer.9 PARP inhibitors like LYNPARZA block the repair mechanism of these cells, causing more cancer cells to die.9

Ben McDonald, Country President, AstraZeneca Australia and New Zealand said AstraZeneca is committed to improving outcomes for ovarian cancer.

“The PBS listing for LYNPARZA is another step to supporting more women and their families facing a diagnosis of ovarian cancer,” Mr McDonald said.  

“This expanded PBS listing means more women with advanced ovarian cancer may be able to access targeted treatment LYNPARZA.

“AstraZeneca will continue to invest in further clinical research to deliver precision medicine for cancer patients, with the aim of transforming survival for Australians living with cancer. ”

Associate Professor Yoland Antill, Medical Oncologist and Cancer Genetics Specialist at Cabrini Hospital, Melbourne said they are pleased that more women will be able to access a targeted therapy for their ovarian cancer.  

“For women with late stage ovarian cancer, it is crucial for them to have as many treatment options as possible to help manage their disease,” said Associate Professor Antill.

“The availability of more testing and treatment options for patients diagnosed with advanced ovarian cancer represents a paradigm shift in the way we treat women. We now have more information to inform our treatment decisions, and as a result more women now have access to a reimbursed targeted therapy for their type of ovarian cancer, even if they do not carry a BRCA mutation.”

Sarah Powell, CEO of Pink Hope, Australia’s hereditary cancer patient support organisation, welcomed the PBS listing for women with ovarian cancer.

“Ovarian cancer is different in every woman, so our hereditary cancer community understands the significance of new targeted treatment option being available on the PBS for another sub-type of ovarian cancer,” said Ms Powell.

“This is really welcome news for many ovarian cancer patients around Australia and their families.”

ABOUT LYNPARZA®2

Indication: LYNPARZA tablets are used to treat newly diagnosed BRCA-mutated advanced ovarian cancer, once once the cancer has responded to treatment with standard platinum-based chemotherapy. It is also used to treat advanced BRCA-mutated advanced ovarian cancer that has recurred and responded to previous treatment with platinum-based chemotherapy; LYNPARZA in combination with bevacizumab (another cancer treatment) is used to treat patients with newly diagnosed homologous recombination deficiency (HRD) positive advanced ovarian cancer. These medicines are used together once the cancer has responded to the first treatment with standard platinum-based chemotherapy. A test known as a HRD test is used to determine whether a woman carries a BRCA mutation, as well as HRD.

Precautions: Patients should inform their doctor if they have or have had any of the following medical conditions: any kidney or liver problems (renal or hepatic impairment), or any blood problems (low red blood cell or low white blood cell counts or low platelet counts).  Patients should inform their doctor if they pregnant or breastfeeding, or planning to become pregnant.

Interactions: Patients should tell their doctor or pharmacist if they are taking any other medicines, including any medicines, vitamins or supplements bought without a prescription from a pharmacy, supermarket or health food shop.

Side Effects: Some of the most common side effects are diarrhoea, nausea, vomiting, indigestion, pain in the stomach area under the ribs, loss of appetite, change in taste of food, cough, headache, dizziness and tiredness, rash and itchy rash on swollen, reddened skin. Serious side effects include shortness of breath, tightness of the chest, wheezing, coughing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin.

Full Consumer Medicine Information can be accessed at:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02547-1&d=20231028172310101

 

                                               Refer to PBS Schedule for full Authority Required Information                                                     

 

- ENDS-

 

Associate Professor Antill has been involved in clinical trials, and served on advisory boards sponsored by AstraZeneca for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Associate Professor Antill, and the opinions expressed are their own. Associate Professor Antill has been briefed by AstraZeneca on the approved use of this product.

Media Contacts

 

AstraZeneca Australia

anzmedia@astrazeneca.com  

 

LYNPARZA is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au.

For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com

 

Notes to editors

 

About ovarian cancer

Approximately 2,000 Australians were diagnosed with ovarian cancer in 20224, and more than 1,000 women died from the same disease.4

Over the next 10 years alone, it is estimated that 10,000 Australian women will lose their lives to ovarian cancer.11

Ovarian cancer can happen at any age, but it is usually in women who have been through menopause, with the average age of diagnosis being age 64.12

Ovarian cancer is often called the silent killer, due to vagueness of symptoms and lack of an early detection test11. Approximately 70 per cent of cases are diagnosed when the cancer is in the advanced stages, having already spread to other parts of the body.11  

About HRD

When our body is unable to repair breaks in DNA this is called homologous recombination deficiency (HRD). It means that, in those with a diagnosis of ovarian cancer and whose tumour tests positive for HRD, cancer cells have a harder time repairing themselves.10

 

About LYNPARZA®2

LYNPARZA® (olaparib) tablets belong to a group of medicines called PARP (Poly (ADP-Ribose) Polymerase enzymes) inhibitors. PARP inhibitors can destroy cancer cells that are

not good at repairing DNA damage. These specific cancer cells can be identified by response to platinum chemotherapy or by looking for faulty DNA repair genes such as BRCA genes.13

 

AstraZeneca in ovarian cancer

AstraZeneca led the way in treating BRCA-mutated high grade serous epithelial ovarian cancer (HGEOC), building on a proud history of transforming the lives of people diagnosed with many forms of cancer.

Now, AstraZeneca is leading the way in the delivery of precision medicine for more types of ovarian cancer with the aim of transforming survival for women living with this devastating form of cancer.

 

About AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, visit www.astrazeneca.com.au

 

References

 

1. Konstantinopoulos P, et al. Cancer Discov. 2015;5(11):1137–1154; 24

2. TGA. Lynparza CMI. 2023. Available: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02547-1&d=20231028172310101 Accessed 28 October 2023.

3. Ovarian Cancer Australia. New challenge to take on Australia’s deadliest female cancer. 2023. Available at: https://www.ovariancancer.net.au/news/113/workout4women Accessed 28 October 2023

4. Cancer Australia. Ovarian cancer. 2023. Available at: https://www.canceraustralia.gov.au/cancer-types/ovarian-cancer/statistics Accessed 28 October 2023

5. Target Ovarian Cancer. Key Facts and Figures. Available: https://targetovariancancer.org.uk/about-us/media-centre/key-facts-and-figures Accessed 28 October 2023.

6. Ovarian Cancer Research Foundation. Why is ovarian cancer so tricky to treat. 2021. Available at: https://www.ocrf.com.au/news/68/why-is-ovarian-cancer-so-tricky-to-treat  Accessed 28 October 2023.

7. PBS. PBAC July 2023 Outcomes. Available at: https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-made-by-the-pbac-july-2023 Accessed 13 December 2023

8. Heitz et al. Cancers. 2023 Feb; 15(3): 818.

9. Target Ovarian Cancer. Homologous recombination deficiency. Available at:

https://targetovariancancer.org.uk/about-ovarian-cancer/genetic-genomic-testing/homologous-recombination-deficiency Accessed May 2023.

10. Medical News Today. What is HRD? 2022. Available at: https://www.medicalnewstoday.com/articles/hrd-positive-ovarian-cancer#What-is-HRD? Accessed 29 October 2023

11. Ovarian Cancer Research Foundation. Facts about Ovarian Cancer. Available at https://www.ocrf.com.au/ovarian-cancer/facts-about-ovarian-cancer Accessed by 29 October 2023

12. Ovarian Cancer Australia. What is my risk of Ovarian Cancer? 2023. Available at https://www.ovariancancer.net.au/page/137/what-is-my-risk Accessed 29 October 2023.

13. EMA. Olaparib Available at: https://www.ema.europa.eu/en/documents/rmp-summary/lynparza-epar-risk-management-plan-summary_en.pdf  Accessed 4 December 2023.

 

AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-18280 November 2023