Eligible Australians with an inherited form of high-risk, early breast cancer may now access a targeted treatment option, following the listing of AstraZeneca’s LYNPARZA® (olaparib) on the Pharmaceutical Benefits Scheme (PBS) from 1 July 2024.
LYNPARZA®, a PARP-inhibitor designed to destroy certain types of cancer cells1, is the first oral therapy available on the PBS which targets HER2-negative (human epidermal growth factor receptor 2 negative), early breast cancer patients with faulty DNA repair genes, known as BRCA (BReast CAncer). These patients are a distinct and usually young population who often present with aggressive disease2.
The reimbursement of LYNPARZA® is for the treatment of patients with HER2-negative, high risk early breast cancer with a confirmed gBRCA1 (germline BRCA1) or gBRCA2 (germline BRCA2) mutation who have previously been treated with neoadjuvant or adjuvant chemotherapy3.
Breast cancer is the most commonly diagnosed cancer among women in Australia, with around 20,000 Australians diagnosed each year, 1,000 of whom are aged under 404.
- More than two thirds of all patients are diagnosed with HER2-negative breast cancer, of which two populations are included: hormone-positive /HER2-negative and hormone-negative /HER2-negative (also known as triple-negative) breast cancer 5;
- Triple-negative breast cancer accounts for 10-15 per cent of all breast cancers and tends to be more common in people aged under 40, or among those carrying a gBRCA1 mutation6;
- Approximately 5 per cent of all breast cancers have a germline BRCA1 or BRCA2 mutation (gBRCAm), equating to roughly 1,000 people diagnosed with breast cancer in Australia each year7;
- HER2-negative, early breast cancer patients with a gBRCA mutation are on average 20 years younger at diagnosis compared with the general breast cancer population.8
These early breast cancer patients are likely to be working and may also have a young family.2 They live "watching and waiting" for their disease to relapse after initial chemotherapy treatment.9
Germline BRCA gene mutation testing is already available in Australia for familial risk assessment10 but will become reimbursed to a broader group of patients with a high risk of disease recurrence to determine their eligibility for LYNPARZA®.1
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 the listing of LYNPARZA® on the PBS.
“The Australian Government’s reimbursement of LYNPARZA® on the PBS is significant for patients with a form of hereditary, high-risk early breast cancer,” Mr McDonald said.
“Hundreds of Australians may now be able to access this medicine on the PBS each year.
“This PBS listing ensures more Australian breast cancer patients have another option for affordable access to new medicines. We will continue to advocate for earlier, faster, fairer access to medicines for all Australians,” Mr McDonald said.
Dr Richard de Boer is a Medical Oncologist at Epworth Freemasons Hospital in Melbourne and treats patients with early breast cancer.
“This treatment option addresses an unmet clinical need for targeted treatments for early breast cancer patients with a gBRCA mutation,” Dr de Boer said.
“Currently, patients diagnosed with germline BRCA-mutated, HER2-negative, high-risk early breast cancer may experience a high rate of the disease recurring, due to its aggressive nature2.
“The listing of LYNPARZA® offers another treatment that will give these patients a chance to delay any cancer relapse11.
“I welcome the news that LYNPARZA® is now available on the PBS as a treatment option for patients with early breast cancer. These patients live with the psychological and physical demands of their high-risk disease while balancing work and family responsibilities.”2
Sarah Powell, CEO of Pink Hope, Australia’s hereditary cancer patient support organisation, welcomed the PBS listing for people with early breast cancer and a germline BRCA mutation.
“There has long been a need for a targeted medicine to treat BRCA-mutated early breast cancer patients and our hereditary cancer community appreciates the availability of this new targeted treatment option on the PBS,” said Ms Powell.
“As a high-risk individual myself, I know that these patients are usually young2 and in the prime of their life – contributing to the community, active members of the workforce and often raising young children and caring for ageing parents, too.
“The listing of LYNPARZA® on the PBS is welcome news for many early breast cancer patients around Australia and their loved ones.”
ABOUT LYNPARZA®1
Indication: LYNPARZA® is indicated as monotherapy to treat a type of breast cancer (BRCA-mutated, HER2-negative) when the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy). Patients should have received chemotherapy medicines before or after surgery. A test is used to determine whether patients have BRCA-mutated breast cancer1.
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). Patients should inform their doctor if they are undertaking IVF, are pregnant or breastfeeding.
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 Information3: Authority Required. Refer to PBS Schedule for full Authority Required Information |
- ENDS-
Dr Richard de Boer 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 Dr de Boer, and the opinions expressed are his own. Dr de Boer 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 Australia4. Approximately 57 Australians are diagnosed each day, equating to over 20,000 Australians each year.4
1 in 7 women and 1 in 600 men are diagnosed with breast cancer in their lifetime.4
On average 9 Australians still die from breast cancer every day.4 In 2023 there were more than 3200 deaths from breast cancer.4
Patients diagnosed with triple-negative breast cancer in the early stages of disease are often younger than 40 years old.12
About LYNPARZA®1
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. 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 June 2024
2. 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 June 2024
3. Pharmaceutical Benefits Advisory Committee Meeting Outcomes November 2023 Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2023-11/pbac-web-outcomes-11-2023-v2.pdf Accessed June 2024
4. National Breast Cancer Foundation. 2021. Breast Cancer Stats. Available at: https://nbcf.org.au/about-breast-cancer/breast-cancer-stats/ Accessed June 2024
5. Breast Cancer Resource Center. Available at https://www.webmd.com/breast-cancer/breast-cancer-her2-negative Accessed June 2024
6. Surveillance, Epidemiology, and End Results Program (SEER) database: https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html#:~:text=These%20cancers%20tend%20to%20be,a%20worse%20prognosis%20(outlook) Accessed June 2024
7. Breast Cancer Network Australia. https://www.bcna.org.au/resource-hub/articles/breast-cancer-in-the-family/ Accessed June 2024
8. O'Shaughnessey et al; Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study; Breast Cancer Research 2020 Oct 27;22(1):114 https://pubmed.ncbi.nlm.nih.gov/33109210/ Accessed June 2024
9. Polyzoi et al. Cost-Effectiveness Analysis of Adjuvant Olaparib Versus Watch and Wait in the Treatment of Germline BRCA1/2-Mutated, High-Risk, HER2-Negative Early Breast Cancer in Sweden. PharmacoEconomics. 2024 Mar;8(2):277-289. https://pubmed.ncbi.nlm.nih.gov/38093030/ Accessed June 2024
10. 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 June 2024
11. Tutt et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. The New England Journal of Medicine. 2021;384:2394-2405 https://www.nejm.org/doi/full/10.1056/NEJMoa2105215 Accessed June 2024
12. Cancer Network. 2019. What characterises breast cancer in adolescent and young adult patients? Available at: https://www.cancernetwork.com/view/what-characterizes-breast-cancer-adolescent-and-young-adult-patients Accessed June 2024
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-19951 June 2024