Australians living with an aggressive form of bladder cancer can access a new immunotherapy option, following the expansion of AstraZeneca’s IMFINZI® (durvalumab) on the Pharmaceutical Benefits Scheme (PBS).1
From 1 April 2026, IMFINZI® is PBS-reimbursed for around 1,000 eligible adults per year living with muscle-invasive bladder cancer (MIBC)2 who are planning to have their bladder removed.
Before surgery, IMFINZI® is used in combination with chemotherapy, followed by IMFINZI® alone after surgery.1
Affecting about one in four of the 3,345 Australians diagnosed with bladder cancer each year3, MIBC is a form of bladder cancer found in the muscle layer of the bladder wall which poses a risk of spreading to lymph nodes and other organs such as the lungs, bones or liver.4
- The standard treatment for MIBC is chemotherapy followed by surgery to remove the bladder, nearby lymph nodes and sometimes nearby organs.5
- Around half of MIBC patients who have had bladder-removal surgery experience their disease returning within three years and around half do not survive beyond five years5 – a rate that has worsened in the past 30 years.5
- Providing people living with MIBC with a reimbursed option for treatment before and after bladder-removal surgery, IMFINZI® is an IV-administered immunotherapy which helps the immune system to recognise and destroy tumour cells that are trying to hide.2
Dr Marie Guillet, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative cancer medicines to Australian patients for more than 40 years, said: “AstraZeneca welcomes the Australian Government’s investment to bring PBS access to IMFINZI for around 1,000 Australians diagnosed with muscle-invasive bladder cancer every year.
“Given the frequent occurrence of muscle-invasive bladder cancer spreading throughout the body, receiving a diagnosis can significantly impact quality of life,” Dr Guillet said.
“AstraZeneca is following the science and we will continue to advocate for earlier and faster access to medicines to support a fairer health system for all Australians living with genitourinary cancers and their loved ones.”
Dr Niara Oliveira, senior medical oncologist at the Mater Hospital Brisbane and Australia’s lead investigator on the global clinical trial of this medicine, welcomed the announcement.
"The expansion of IMFINZI on PBS addresses an area of high unmet need for patients facing muscle-invasive bladder cancer,” Dr Oliveira said.
“This listing means we can bring the use of immunotherapy forward, allowing more patients to access this treatment in conjunction with chemotherapy and surgery.”
Adam Lynch, who founded the patient advocacy and support group BEAT Bladder Cancer Australia following the death of his wife Anna to MIBC at the age of 45, just 14 months after her diagnosis, welcomed IMFINZI’s expansion on the PBS.
“Patients with muscle-invasive bladder cancer face the confronting decision to undergo life-changing surgery to have their bladder removed. Yet even after bladder removal, survival rates remain alarmingly low,” Mr Lynch said.
"We welcome PBS access to IMFINZI® as a new treatment option for our patient community.”
ABOUT IMFINZI7
Indication: IMFINZI® in combination with chemotherapy for the treatment of patients with muscle-invasive bladder cancer who are planning to undergo bladder-removal surgery. Before surgery, IMFINZI® is used in combination with chemotherapy (gemcitabine and cisplatin), followed by IMFINZI® alone after surgery.1
Precautions: Patients should inform their doctor if they have any of the following medical conditions: immune system problems such as Crohn’s disease, 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.
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: Common side effects of IMFINZI® in combination with chemotherapy (gemcitabine and cisplatin) before surgery include: low number of red and white blood cells and blood platelets; abnormal kidney function tests; diarrhoea; stomach pain; constipation; nausea and vomiting; fatigue; fever; abnormal liver function tests; decreased appetite; skin rash or itchiness; underactive thyroid gland; inflammation of the nerves.
Common side effects of taking IMFINZI as a monotherapy after surgery include: cough, diarrhoea, stomach pain, skin rash or itchiness, fever, swelling of the legs, upper respiratory tract infection, underactive thyroid gland that can cause tiredness or weight gain (hypothyroidism), overactive thyroid gland which may cause many different symptoms including weight loss, hand tremors, rapid or irregular heartbeat.
More information can be found in the IMFINZI® Consumer Medicine Information here: https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimfip10823
PBS Information1: Authority required (STREAMLINED): Refer to PBS Schedule for full information. |
- ENDS-
Dr Niara Oliveira 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 Oliveira, and the opinions expressed are her own. Dr Oliveira has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
IMFINZI® (durvalumab) is a registered 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 or email Medical Information enquiries to medinfo.australia@astrazeneca.com
Notes to editors
Bladder cancer in Australia
Bladder cancer begins when abnormal cells in the bladder’s inner lining grow and divide in an uncontrolled way.4
About one in 140 Australian males will be diagnosed with bladder cancer before the age of 75, making it one of the 10 most common cancers in Australian males.4 Among Australian women, the risk is about one in 560, although it is often diagnosed at an advanced stage.4
In 2025 it was estimated that 3,345 Australians were diagnosed with bladder cancer3, the most common symptom of which is blood in the urine.
Risk factors that can increase the risk of developing the disease4 include but are not limited to:
· Smoking tobacco
· Being older and male
· Workplace exposure to certain chemicals
· Having one or more close relatives diagnosed with bladder cancer or having inherited a gene linked to bladder cancer.
Affecting around a quarter6 of people diagnosed with bladder cancer, muscle-invasive bladder cancer is a form of bladder cancer which has spread into the muscle layer of the bladder wall.
About IMFINZI®7
Containing 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 more than 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com.au
References
2. www.sciencedirect.com/topics/medicine-and-dentistry/muscle-invasive-bladder-cancer
3. www.canceraustralia.gov.au/cancer-types/bladder-cancer/bladder-cancer-statistics-australia
4. www.cancer.org.au/assets/pdf/understanding-bladder-cancer-booklet
5. www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/survival
6. www.sciencedirect.com/science/article/abs/pii/S0147027214000403
7. IMFINZI Consumer Medicine Information https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimfip10823
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-24807 March 2026