Australians living with an aggressive form of metastatic breast cancer1 can now access a new targeted treatment option, following the announcement that AstraZeneca and Daiichi Sankyo’s ENHERTU® (trastuzumab deruxtecan) will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 November 2023 for eligible HER2-positive metastatic breast cancer patients.
Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. It is a targeted cancer therapy designed to target and kill tumour cells expressing the HER2 protein2.
The reimbursement of ENHERTU® is for the treatment of HER2 (human epidermal growth factor receptor 2) positive breast cancer for patients whose disease has progressed following treatment with at least one prior HER2 directed therapy for metastatic breast cancer, or patients whose condition has progressed during or within six months following adjuvant (post-surgical) treatment with a HER2 directed therapy3.
- 20,000 Australians are diagnosed with breast cancer each year, and 1,000 have metastatic (advanced or late stage) breast cancer at first diagnosis4.
- 1 in 5 patients with breast cancer are considered HER2-positive, which is an aggressive form of the disease with a high rate of recurrence and poorer survival1. Regardless of age at diagnosis, patients with metastatic breast cancer need new treatment options to help them live longer.
- ENHERTU® (trastuzumab deruxtecan) is a newly PBS listed targeted treatment option for eligible Australian patients diagnosed with HER2-positive metastatic breast cancer that aims to reduce the risk of disease progression5.
Metastatic breast cancer is an invasive breast cancer where the cancer has spread to other parts of a patient’s body, such as their bones, lungs, liver or brain6. Currently there are no cures7. Patients with metastatic breast cancer receive ongoing treatment, with the aim to slow the progress of the disease and maintain quality of life7.
Patients with metastatic breast cancer live with the psychological and physical demands of their disease, while balancing their everyday lives including working and having family and carer responsibilities. These patients often report feeling overlooked and invisible in the health care system8.
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, said:
“The inclusion of ENHERTU® on the PBS is important for patients living with HER2-positive metastatic breast cancer.
“We estimate that hundreds of new Australian patients will be able to access this medicine on the PBS each year. We are proud to deliver access to this targeted medicine which may give patients more time with their loved ones13.
“We commend the Australian Government for ensuring more Australian cancer patients have affordable access to new cancer medicines, “Mr McDonald said.
Dr Michelle White is a Medical Oncologist at Cabrini Brighton in Melbourne and treats patients with metastatic breast cancer:
“While survival outcomes for patients with metastatic breast cancer have improved significantly over the last 20 years9, currently only one third of patients are still alive five years after being diagnosed10.
“The inclusion of ENHERTU® on the PBS is an important step forward in the management of HER2-positive metastatic breast cancer. This targeted treatment directly attacks the HER2 cancer cells which aims to stop the growth11 and progression of the disease12. Eligible patients who progress on their initial therapy now have another treatment option for their metastatic disease," Dr White said.
ABOUT ENHERTU®13
Indication: ENHERTU® is used to treat adults who have HER2-positive breast cancer that has spread to other parts of the body or cannot be taken out by surgery and who have also received prior treatment with trastuzumab and a taxane for metastatic disease or have received one prior treatment for breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer.
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; rash; dry eye; 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-
Dr White 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 White, and the opinions expressed are their own. Dr White 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.10
1 in 7 women and 1 in 600 men are diagnosed with breast cancer in their lifetime.10
On average 9 Australians still die from breast cancer every day.10 In 2022 there were more than 3200 deaths from breast cancer.14
Patients diagnosed with HER2-positive breast cancer in the early stages of disease are often younger than 40 years old.15
The average age of a patient with HER2-positive metastatic breast cancer who participated in the registration trial was 54 years old.5
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. Mitri, Z. et al. The HER2 Receptor in Breast Cancer: Pathophysiology, Clinical Use, and New Advances in Therapy. Chemotherapy research and practice, 2012, 743193. https://doi.org/10.1155/2012/743193
2. Targeted Oncology. 2023. Expanded Roles for Trastuzumab Deruxtecan in HER2+ Breast Cancer. Available at: https://www.targetedonc.com/view/expanded-roles-for-trastuzumab-deruxtecan-in-her2-breast-cancer Accessed 29 September 2023.
3. Pharmaceutical Benefits Advisory Committee Meeting Outcomes July 2023 Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2023-07/pbac-web-outcomes-07-2023-v2.pdf
4. 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 2021
5. Cortes et al. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. The New England Journal of Medicine, 2022, 386:1143-1154. https://www.nejm.org/doi/10.1056/NEJMoa2115022
6. 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 1 March 2023
7. BreastCancer.org. 2023. Myths and Misconceptions About Metastatic Breast Cancer. Available at: https://www.breastcancer.org/types/metastatic/myths Accessed 1 March 2023.
8. Breast Cancer Network Australia. 2022. Making Metastatic Breast Cancer Count. Available at: https://www.bcna.org.au/media/8823/bcna_mbc_issues_paper_digital_single_fy22.pdf Accessed 1 March 2023.
9. 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 19 May 2023
10. National Breast Cancer Foundation. 2021. Breast Cancer Stats. Available at: https://nbcf.org.au/about-breast-cancer/breast-cancer-stats Accessed March 2023
11. BreastCancer.org. 2023. Enhertu. Available at: https://www.breastcancer.org/treatment/targeted-therapy/enhertu Accessed 18 May 2023.
12. Medline Plus. 2023. Cancer Treatments. Available at: https://medlineplus.gov/ency/patientinstructions/000901.htm#:~:text=Immunotherapy%20works%20by%3A,other%20parts%20of%20the%20body Accessed 18 May 2023.
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 25 August 2023.
14. Cancer Australia. 2023. Breast Cancer in Australia statistics. Available at: https://www.canceraustralia.gov.au/cancer-types/breast-cancer/statistics Accessed 18 May 2023
15. 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 26 April 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-16370 October 2023