Australians living with locally advanced or metastatic biliary tract cancer (BTC), a rare and aggressive gastrointestinal (GI) cancer, will be able to access IMFINZI® (durvalumab) on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2023 providing eligible patients with access to the first new treatment for this incurable disease in over ten years.2,3
This reimbursement of IMFINZI® is for the first-line treatment of locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine plus cisplatin).3
- Biliary Tract Cancer (BTC) is a group of rare and aggressive cancers occurring in the bile ducts and the gallbladder. Approximately 1,300 Australians are diagnosed with BTC each year.4 BTC currently has one of the worst survival rates of all cancers in Australia, with only one in five people diagnosed surviving more than five years.4
- More than two-thirds of people with advanced BTC are unable to have surgery because the cancer has spread or is inoperable by the time it is diagnosed as there are often no symptoms in the early stages, contributing to poor prognosis and reduced quality of life.5,6
- Current treatment for patients in first-line locally advanced and metastatic BTC is limited to chemotherapy.5
IMFINZI® is the first immunotherapy approved in Australia to be used in combination with chemotherapy for the treatment of this aggressive and incurable GI cancer in first-line locally advanced and metastatic setting.1
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered life-saving cancer medicines to Australians for over 40 years, said:
“AstraZeneca is proud to be able to address the significant unmet need of patients living with this rare and aggressive gastrointestinal cancer.
“The PBS listing of a new combination cancer treatment option, IMFINZI® for Australians with locally advanced or metastatic biliary tract cancer, provides these patients with the first new treatment option for this disease in over ten years.
“We are pleased that the Government continues to support innovative medicines that help to reduce the burden of disease, regardless of how rare or aggressive the cancer is, and improve the quality of life for hundreds of Australian patients.”
Professor Niall Tebbutt, Director of Medical Oncology, Olivia Newton-John Cancer Wellness and Research Centre, who treats patients with biliary tract cancer said:
“The inclusion of IMFINZI® (durvalumab) on the PBS for advanced biliary cancer provides an important treatment option for patients with this rare and aggressive type of gastrointestinal cancer.
“IMFINZI® is the first immunotherapy for the treatment of biliary cancer, and it is exciting to now have reimbursed access to this treatment for Australian patients.”
Doug Hawkins, CEO of Pancare Foundation, a leading charity committed to raising awareness for upper gastrointestinal cancers said:
“The inclusion of IMFINZI® on the PBS is wonderful news for patients living with locally advanced or metastatic biliary tract cancer as there has been limited progress in new therapies over the past decade.
“Pancare Foundation welcomes any new therapy that offers patients greater choice regarding treatment that aims to provide them with more time with their families.
“To provide the greatest impact, treatments must be affordable for patients. The PBS listing of IMFINZI® significantly reduces the cost of a course of treatment."
ABOUT IMFINZI®3
Indication: IMFINZI® is used in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).
Precautions: Patients should inform their doctor if they have any of the following medical conditions: immune system problems such as Crohn’s disease, ulcerative colitis or lupus; have had an organ transplant; have lung or breathing problems or have liver problems. Patients should inform their doctor if they are pregnant or intend to become pregnant, are breastfeeding or intending to breastfeed, or if under the age of 18 years.
Interactions: Patients 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 side effects include: low number of red blood cells (anaemia), low number of white blood cells (neutropenia and leukopenia), low number of platelets (thrombocytopenia), diarrhoea, abdominal pain, constipation, nausea, vomiting, feeling tired or weak, fever, abnormal liver tests, decrease in appetite, skin rash and itchiness.
More information can be found in the IMFINZI® Consumer Medicine Information here: https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimfip10823
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 Information: Authority Required. Refer to PBS Schedule for full Authority Required Information. |
- ENDS -
In relation to this AstraZeneca media announcement, no compensation was provided to Professor Tebbutt and the opinions expressed are their own. Professor Tebbutt has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
anzmedia@astrazeneca.com
IMFINZI® is a trademark of the AstraZeneca group of companies. 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
Biliary Tract Cancer in Australia
Biliary tract cancer (BTC) is a group of rare and aggressive cancers occurring in the bile ducts and gallbladder that kills one Australian almost every day.6 Approximately 1,300 Australians are diagnosed with BTC each year.4 The prognosis of advanced biliary tract cancer, including patients with locally advanced or metastatic disease, is poor with a 5-year overall survival of less than 10%.5
Like many gastrointestinal cancers, BTC is most effectively treated when it is found early, but this is often difficult as BTC generally does not cause symptoms in its early stages.4
BTC is most commonly diagnosed in people between the ages of 60 and 75 years and affects slightly more men than women.7 The main risk factor for bile duct cancer (a type of BTC, also known as cholangiocarcinoma) is long-term inflammation of the bile ducts which may be caused by liver problems such as hepatitis and fatty liver disease.8
About IMFINZI®3
IMFINZI® contains the active ingredient durvalumab. IMFINZI® is a monoclonal antibody, a type of protein. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint inhibitors. It works with the patient’s immune system to destroy cancer cells.
IMFINZI® 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
References
- Yan, X., Huimin, Z., Lai, Y. et al. Efficacy and Safety of First-Line Targeted Treatment and Immunotherapy for Patients with Biliary Tract Cancer: A Systematic Review and Meta-Analysis. Cancers (Basel) 2022 Dec 21;15(1):39. Doi: 10.3390/cancers15010039 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9817514/#B4-cancers-15-00039 Accessed November 2023
- Valle J., Wasan H., Palmer D.H., Cunningham D., Anthoney A., Maraveyas A., Madhusudan S., Iveson T., Hughes S., Pereira S.P., et al. Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. N. Engl. J. Med. 2010;362:1273–1281. Doi: 10.1056/NEJMoa0908721.
- TGA Approval 2023. Product information for Imfinzi. Available at: https://medsinfo.com.au/api/documents/Imfinzi_PI?format=pdf. Accessed October 2023
- What is cholangiocarcinoma? GI Cancer. Available at: https://gicancer.org.au/news/what-is-cholangiocarcinoma/ Published February 2, 2022. Accessed October 2023
- Hunter, L, Soares, H. Quality of Life and Symptom Management in Advanced Biliary Tract Cancers. Cancers (Basel) 2021 Oct 13(20): 5074 doi: 10.3390/cancers13205074 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533827/ Accessed November 2023
- Biliary cancer awareness campaign success. Pancare Foundation. Available at: https://www.pancare.org.au/biliary-cancerawareness-campaign-success/ Accessed October 2023
- ESMO. What is Biliary Tract Cancer. Available at: https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf Accessed October 2023
- Bile duct cancer. Cancer Council NSW. Available at: https://www.cancercouncil.com.au/bile-duct-cancer/ Accessed October 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-18179 November 2023