Eligible Australians with an inherited form of metastatic breast cancer may now be able to access AstraZeneca’s LYNPARZA®1 (olaparib), a targeted treatment option, following a broadening of its Pharmaceutical Benefits Scheme (PBS) listing from 1 January 2025.
LYNPARZA®, a PARP-inhibitor designed to destroy certain types of cancer cells2, is the first oral therapy available on the PBS for eligible HER2-negative (human epidermal growth factor receptor 2 negative) metastatic breast cancer patients with faulty DNA repair genes, known as BRCA (BReast CAncer) genes.
The PBS listing of LYNPARZA® now includes the treatment of patients with HER2-negative metastatic breast cancer with a confirmed gBRCA1 (germline BRCA1) or gBRCA2 (germline BRCA2) pathogenic or likely pathogenic gene variant and who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting1.
Breast cancer is the most common cancer among women in Australia3, and around 1,050 of the 21,000 Australians diagnosed each year carry a germline BRCA mutation4. These patients tend to be diagnosed at a younger age5.
World-first data revealed the metastatic breast cancer population in Australia is much larger than previously projected, with around 7,900 people in NSW alone7 estimated to be living with this invasive form of cancer that has spread to other parts of the body, such as the bones, lungs, liver or the brain8.
As part of this PBS listing, the Government has also announced germline BRCA testing will be reimbursed for all metastatic breast cancer patients11, and not just those with a high hereditary risk, to determine their eligibility for LYNPARZA®.
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered new breast cancer medicines to Australians for more than 40 years, welcomed this PBS listing.
“Hundreds of additional Australians with an inherited form of metastatic breast cancer may now be able to benefit from this targeted treatment,” Mr McDonald said.
“This PBS listing ensures more Australians with breast cancer have another option for affordable access to new medicines.
“We will continue to advocate for earlier, faster, fairer access to diagnosis and medicines for all Australians,” Mr McDonald said.
Professor Fran Boyle is a Medical Oncologist at The Mater Hospital in North Sydney who treats patients with metastatic breast cancer, and a founding member of MBC Action Australia, a newly formed national, grassroots, consumer-led advocacy organisation for people with metastatic breast cancer.
“The listing of LYNPARZA® addresses an unmet clinical need for targeted treatments for metastatic breast cancer patients who carry a gBRCA mutation,” Professor Boyle said.
“The mutation can be found via a blood test arranged by their oncologist, and I am pleased this genetic testing is now reimbursed for all breast cancer patients and not just those with a strong hereditary risk.
“Patients with a gBRCA mutation tend to be younger than others with metastatic breast cancer, and they often balance work and family responsibilities while dealing with the significant psychological and physical demands of a metastatic diagnosis.”
Sarah Powell, CEO of Inherited Cancers Australia, Australia’s leading hereditary cancer patient support organisation, welcomed the broadening of LYNPARZA‘s listing on the PBS.
“Our community appreciates the listing of a new targeted treatment option for germline BRCA patients with metastatic breast cancer,” said Ms Powell.
“Hereditary breast cancer tends to affect women when they are in the prime of their lives, casting a shadow over families and impacting multiple generations.
“The expansion of LYNPARZA® on the PBS is welcome news for many germline BRCA metastatic breast cancer patients and their loved ones around Australia and it also highlights the critical importance of genetic testing to inform options for targeted treatment.”
ABOUT LYNPARZA®2
Indication: LYNPARZA® is indicated as monotherapy to treat a type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour. Patients should have received chemotherapy medicines either before or after their cancer has spread. A test is used to determine if a patient has germline BRCA-mutated breast cancer.2
Precautions: Patients should inform their doctor if they have any of the following medical conditions: have or have had any lung problems, any kidney problems, any heart problems or any blood problems (low blood count). Do not take this medicine if you are pregnant or if you (man or women) are planning to have a baby. Do not breast-feed if you are taking this medicine.
Interactions: Patients should inform their doctor if they have any other medical conditions, including problems with their kidneys or liver (renal or hepatic impairment) and problems with their blood (e.g. low red blood cell counts, low white blood cell counts or low platelet counts), or are taking any medicines for any other condition.
Side Effects: Side effects include 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. 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.
More information can be found in the LYNPARZA® Consumer Medicine Information here: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02547-1&d=20231028172310101
PBS Information1:
Authority Required. Refer to PBS Schedule for full Authority Required Information
- ENDS-
Professor Fran Boyle has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Boyle, and the opinions expressed are her own. Professor Boyle has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
LYNPARZA® is a trademark of AstraZeneca. 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
Notes to editors
Breast cancer in Australia
Breast cancer is the most commonly diagnosed cancer among women in Australia3. Approximately 58 Australians are diagnosed each day, equating to over 21,000 Australians each year.3
1 in 7 women and 1 in 550 men are diagnosed with breast cancer in their lifetime.3
On average 9 Australians still die from breast cancer every day.3 In 2023, there were more than 3300 deaths from breast cancer.3
Women with gBRCA1 and/or gBRCA2 gene mutations have an up to 72 per cent risk of developing breast cancer in their lifetime.10
Around 7,900 people in NSW alone are estimated to be living with metastatic breast cancer7, when cancer has spread beyond the breast to other parts of the body, most often the bones, lungs, liver or brain. It is treatable but not currently curable9.
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.
References
1. https://www.pbs.gov.au/medicinestatus/document/1210.html
2. TGA. Lynparza CMI. February 2024. Available: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02547-1&d=20231028172310101 Accessed October 2024
3. National Breast Cancer Foundation. 2021. Breast Cancer Stats. Available at: https://nbcf.org.au/about-breast-cancer/breast-cancer-stats/ Accessed October 2024
4. Breast Cancer Network Australia. https://www.bcna.org.au/resource-hub/articles/breast-cancer-in-the-family/ Accessed October 2024
5. Becourt S et al. J Clin Oncol. 2018;36(15_suppl):Abstract e13522. Available: https://ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.e13522 Accessed October 2024
6. EviQ guidelines. Available at https://www.eviq.org.au/cancer-genetics/adult/genetic-testing-for-heritable-pathogenic-variants/620-brca1-brca2-and-palb2-truncating-variants Accessed October 2024
- Breast Cancer Network Australia. 2023. What is metastatic breast cancer? Available at: https://www.bcna.org.au/metastatic-breast-cancer/what-is-metastatic-breast-cancer/ Accessed October 2024
- BreastCancer.org. 2023. Myths and Misconceptions About Metastatic Breast Cancer. Available at: https://www.breastcancer.org/types/metastatic/myths Accessed October 2024
10. Breast Cancer Network Australia. Genetics and risk of breast cancer 2023; Available from: https://www.bcna.org.au/resource-hub/articles/genetics-and-risk-of-breast-cancer/
11. Medicare Benefits Schedule Online https://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/news-250101
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-21231 December 2024