Australians with a form of metastatic breast cancer1 can now access a targeted treatment option, following news that AstraZeneca and Daiichi Sankyo’s ENHERTU® (trastuzumab deruxtecan) is being expanded on the Pharmaceutical Benefits Scheme (PBS) to include eligible HER2-low (human epidermal growth factor receptor 2 low) patients from 1 September 2024.
ENHERTU® is a scientifically engineered HER2-directed antibody drug conjugate (ADC) jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. It is a targeted cancer therapy designed to kill tumour cells expressing the HER2 protein.2
The PBS listing of ENHERTU® for the treatment of HER2-low breast cancer is for patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) disease should have also received prior endocrine therapy.3
Metastatic breast cancer (mBC) is an invasive cancer that has spread to other parts of a patient’s body, such as their bones, lungs, liver or brain4. Currently there are no cures5. Patients with metastatic breast cancer receive ongoing treatment, with the aim to slow the progression of the disease and maintain their quality of life6.
- Of the 20,000 Australians diagnosed with breast cancer each year, approximately 22 per cent progress to metastatic (advanced or late stage) disease within 14 years7 and 1,000 have metastatic breast cancer at first diagnosis8.
- Around 55 per cent of all breast cancer patients are classified as HER2-low9, a distinct subtype characterised by low levels of the HER-2 protein.
As outlined in a report commissioned by AstraZeneca, Australians living with metastatic breast cancer face significant psychological and physical demands as they balance their everyday lives including working and caring for their families10. The report identifies three critical priorities for those with mBC and their families: the need for greater visibility in the healthcare system, increased dedicated support, and improved access to information.
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative breast cancer medicines to Australian patients for more than 40 years, welcomed the new listing.
“More than 1,000 additional Australian patients may now be able to access ENHERTU® on the PBS each year,” Mr McDonald said.
“AstraZeneca is following the science and exploring new ways to diagnose and treat breast cancer so that patients have targeted treatment options available to them.
“We will continue to advocate for earlier, faster, fairer access to medicines for the benefit of all Australians and those who love them,” Mr McDonald said.
Masaaki Kotaki, Managing Director of Daiichi Sankyo Australia, said: “Our alliance with AstraZeneca is a testament to collaboration, with a shared commitment to breast cancer patients at the core. Together, we’re focused on advancing science for patients and their families.”
Professor Elgene Lim, the Breast Oncology lead at St Vincent's Hospital, said: “Survival outcomes for patients with metastatic breast cancer have improved significantly over the past 20 years11, but still only one-third of patients are alive five years after their diagnosis12.
“ENHERTU® works by targeting HER2-expressing tumour cells and delivering a dose of chemotherapy direct to the cancer and its surrounding cells2.
“Its expansion on the PBS to include the management of HER2-low metastatic disease provides a targeted treatment option that addresses an area of high unmet clinical need2 for these patients," Professor Lim said.
Rachelle Panitz, managing director and founder of breast cancer charity So Brave, said the PBS listing was welcome news.
“This PBS listing will enable affordable access to this treatment option for Australians living with HER2-low metastatic breast cancer,” Ms Panitz said.
“This is welcomed by the So Brave community and their loved ones, who manage the relentless financial, physical and psychological impacts of this disease every day.”
ABOUT ENHERTU®13
Indication: ENHERTU® is used to treat adults with unresectable or metastatic human epidermal growth factor receptor 2 low (HER2-low) breast cancer that cannot be removed by surgery or that has spread to other parts of their body and who have received prior chemotherapy for metastatic disease, or their disease has returned during or within 6 months of completing adjuvant chemotherapy (after surgery). If the breast cancer is also hormone receptor positive (HR+), they should have received hormonal therapy. A test may be performed to make sure ENHERTU is right for you.
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: Patient should inform their doctor if they are taking any other medicines, including any medicines, vitamins or supplements without a prescription from a pharmacy, supermarket or health food shop.
Side Effects: Very common effects include: nausea; fatigue; vomiting; hair loss; constipation; feeling less hungry; diarrhoea; coughing; stomach pain; headache; fever; infections of the nose, nasal passages, throat, voice box and vocal cords; sores in or around your mouth; difficulty breathing; indigestion; severe nosebleeds; lung problems (interstitial lung disease/pneumonitis); rash; dizziness; pain in muscles and bone; weight loss; decrease in the number of red blood cells; decrease in the number of neutrophils; decrease in the number of platelets; decrease in the number of white blood cells; decrease in the number of lymphocytes, blood tests showing increased level of liver enzymes such as transaminases; low potassium in the blood.
More information can be found in the ENHERTU® Consumer Medicine Information here: https://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apcenher10123
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 http://www.tga.gov.au/reporting-problems
PBS Information3: Authority Required. Refer to PBS Schedule for full Authority Required Information. |
- ENDS-
Professor Elgene Lim 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 Lim, and the opinions expressed are their own. Professor Lim has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
ENHERTU® is a trademark of the Daiichi Sankyo Company limited, used under license by 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 or email Medical Information enquiries to medinfo.australia@astrazeneca.com
Notes to editors
Breast cancer in Australia
Breast cancer is the most commonly diagnosed cancer among women in Australia. Approximately 57 Australians are diagnosed each day, equating to over 20,000 Australians each year.12
1 in 7 women and 1 in 600 men are diagnosed with breast cancer in their lifetime.12
On average, 9 Australians die from breast cancer every day.12 In 2022 there were more than 3200 deaths from breast cancer.14
HER2-low expression occurs in both HR-positive and HR-negative disease.15
HER2 testing is routinely used to determine appropriate treatment options for patients with metastatic breast cancer. Targeting the lower range of expression in the HER2 spectrum may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.2
About ENHERTU® 13
ENHERTU® contains the active ingredient trastuzumab deruxtecan. ENHERTU® is made up of a monoclonal antibody connected to a medicine intended to kill cancer cells. The monoclonal antibody delivers the medicine to cancer cells that express HER2 proteins. Once ENHERTU® enters the cell, the medicine becomes active and kills the cancer cells.
ENHERTU® is prescribed and administered to patients in a hospital or clinic via infusion.
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, please visit www.astrazeneca.com.au
Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu.
References
1. Breast Cancer Research Foundation. https://www.bcrf.org/blog/her2-low-breast-cancer-explained/ Accessed 2 August 2024
2. Shanu Modi et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. New England Journal of Medicine 2022. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2203690 Accessed 2 August 2024
3. Pharmaceutical Benefits Advisory Committee Meeting Outcomes November 2023. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2023-11/files/trastuzumab-deruxtecan-psd-nov-2023.pdf Accessed July 2024
4. 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 2 August 2024
5. BreastCancer.org. 2023. Myths and Misconceptions About Metastatic Breast Cancer. Available at: https://www.breastcancer.org/types/metastatic/myths Accessed 2 August 2024
6. Breast Cancer Network Australia. 2022. Making Metastatic Breast Cancer Count. Available at: https://www.bcna.org.au/latest-news/bcna-news/making-metastatic-breast-cancer-count/
7. Lord et al. Long-term risk of distant metastasis in women with non-metastatic breast cancer and survival after metastasis detection: a population-based linked health records study. MJA 217 (8) 402-409 (2022) https://onlinelibrary.wiley.com/doi/10.5694/mja2.51687 Accessed August 2024
8. Australian Government, Cancer Australia. 2019. Top 10 best practices for people with metastatic breast cancer. Available at: https://www.canceraustralia.gov.au/about-us/news/top-10-best-practices-people-metastatic-breast-cancer Accessed August 2024
9. Denkert C, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Oncol. 2021 Aug;22(8):1151-1161. Available at https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(23)00136-6/fulltext Accessed August 2024
10. ‘Out From The Shadows: The reality of living with metastatic breast cancer in Australia’ Available at: https://www.astrazeneca.com.au/news/position-statements.html Accessed August 2024
11. Miglietta et al. Major advancements in metastatic breast cancer treatment: when expanding options means prolonging survival. ESMO Open 2022. Available at: https://www.esmoopen.com/article/S2059-7029(22)00030-8/fulltext Accessed August 2024
12. National Breast Cancer Foundation. 2021. Breast Cancer Stats. Available at: https://nbcf.org.au/about-breast-cancer/breast-cancer-stats Accessed August 2024
13. TGA. 2021. Consumer Medicine information for Enhertu. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-01055-1&d=20230825172310101 Accessed July 2024
14. Cancer Australia. 2023. Breast Cancer in Australia statistics. Available at: https://www.canceraustralia.gov.au/cancer-types/breast-cancer/statistics Accessed August 2024
15. Miglietta F, et al. Evolution of HER2-low expression from primary to recurrent breast cancer. Available at: https://pubmed.ncbi.nlm.nih.gov/34642348/ Accessed August 2024
16. Eiger D et al The Exciting New Field of HER2-low breast cancer treatment. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957750/ Accessed August 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-20476 August 2024