New treatment option on the PBS for locally advanced or metastatic bladder cancer
Astellas Pharma Australia
- PADCEVTM in combination with pembrolizumab has been added to the Pharmaceutical Benefits Scheme for first-line (initial) treatment of locally advanced and metastatic bladder cancers1
- In Australia, bladder cancer survival rates have gotten worse over the last 30–40 years, underscoring the need for new treatment options2,3
- Chemotherapy has been the main treatment used when bladder cancer has spread4
SYDNEY, 1 September 2026 – Astellas Pharma Australia Pty Ltd today announced PADCEVTM (enfortumab vedotin) in combination with pembrolizumab has been listed on the Pharmaceutical Benefits Scheme (PBS) for first-line treatment of locally advanced or metastatic urothelial cancer.1 For the last 40 years, chemotherapy has been the main treatment used for people with urothelial cancer that has spread outside the bladder.4
An estimated 3,345 Australians were diagnosed with bladder cancer in 2025,2 with 80–90% of those cases likely to be urothelial cancers.5 Urothelial cancers start in the inner lining of the bladder wall (urothelial cells) and can move into the outer muscle wall of the bladder or to other parts of the body.5 When this occurs, they are referred to as locally advanced or metastatic, depending on whether the cancer has spread into surrounding tissues or organs or other, more distant parts of the body.6
Unlike other more common cancers, the survival rate for bladder cancer has gotten worse over the last 30–40 years in Australia.2,3 2,3 In the late 1980s, nearly two in three people (66%) with bladder cancer were expected to be alive five years after diagnosis, on average.2 By 2017, the average five-year survival rate had dropped to 57%, according to the latest data.2
Associate Professor Andrew Weickhardt, a Medical Oncologist with a specialist interest in genitourinary cancers including bladder cancer said: “Effective new first-line treatment approaches for locally advanced and metastatic urothelial cancer have been long-awaited. This is a major change to just using chemotherapy in the first-line treatment for these patients. Thanks to advances in drug design and large clinical trials, we can now see improvements in relative survival rates for bladder cancer by combining PADCEV in combination with pembrolizumab.”7
Adam Lynch, CEO of BEAT Bladder Cancer Australia said better awareness of bladder cancer symptoms and the importance of acting quickly on these symptoms is critical.
“Bladder cancer has not received the same level of attention or investment as many other cancers and that means most people simply don’t know what to look out for,” Mr Lynch said.
“Symptoms can be easy to dismiss or difficult to talk about and that can delay people seeking help. Symptoms are also often misdiagnosed as other common urinary conditions. Too often, people are diagnosed when the disease has already spread, when it’s harder to treat and options have been limited. We need this to change if we want to see survival rates from bladder cancer improve.”
The most common symptoms of bladder cancer include blood in the urine, changes in urination such as needing to go more often or urgently, pain or a burning feeling when urinating. Less common is pain in the lower abdomen or back.8
Dr Christina Moravski, Head Medical Affairs, Astellas Australia, welcomed the PBS listing.
“We thank the government for adding PADCEV in combination with pembrolizumab onto the PBS for first-line treatment of locally advanced or metastatic urothelial cancer, creating access to an alternative treatment option to chemotherapy for suitable patients.
“We remain committed to investing in research that advances our understanding of difficult to treat cancers and helping to bring new treatment options to Australia that advance the standard of cancer care, particularly in areas where there continues to be a significant unmet need,” Dr Moravski said.
The appropriate treatment for an individual is for their healthcare professional to decide, in consultation with the patient.
– ENDS –
Issued by SenateSHJ on behalf of Astellas Australia. For further information, please contact:
|
|
▼This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Side effects should be reported to the treating health professional or directly to the TGA at www.tga.gov.au/reporting‑problems
Access the Consumer Medicine Information here or by scanning the QR code:
|
WARNING: SERIOUS SKIN REACTIONS. Tell your doctor right away if you have signs of a severe skin reaction: rash or itching that continues to get worse or comes back after treatment, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms or swollen lymph nodes. |
PADCEV and the PADCEV device are trademarks jointly owned by Agensys, Inc., and Seagen Inc. © 2026 Astellas Pharma Australia Pty Ltd. All rights reserved. Astellas Pharma Australia Pty Ltd ABN 81 147 915 482. Suite 2.01, 2 Banfield Road, Macquarie Park, NSW 2113. Date of preparation: August 2026 MAT-AU-PAD-2026-00066.
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
About BEAT Bladder Cancer Australia
Purpose: To create awareness, connection, and hope for everyone touched by bladder cancer.
Strategic Pillars:
- Community Awareness - A more aware, informed and healthier community.
- Information & Support - A cared for, supported and empowered community.
- Health Professional Education - A knowledgeable & educated health professional sector.
- Advocacy - Improved patient health outcomes & enhanced quality of life.
Visit www.beatbladdercanceraustralia.org.au/ for more information.
###
References:
- Australian Government Department of Health, Disability and Ageing. The Pharmaceutical Benefits Scheme. 2026. [Online] Available at: www.pbs.gov.au
- Cancer Australia. Bladder cancer statistics in Australia. [Online] Available at: www.canceraustralia.gov.au/cancer-types/bladder-cancer/bladder-cancer-statistics-australia Last accessed: May 2026.
- BEAT Bladder Cancer Australia. 2024. Bladder Cancer Information Summary. [Online] Available at: www.beatbladdercanceraustralia.org.au/wp-content/uploads/2024/10/2024-Bladder-Cancer-Information-Summary.pdf Last accessed: May 2026.
- Cancer Australia. 2024. Bladder cancer treatment options. [Online] Available at: https://www.canceraustralia.gov.au/cancer-types/bladder-cancer/treatment-options Last accessed August 2026
- Cancer Australia. 2024. Types of bladder cancer. [Online] Available at: www.canceraustralia.gov.au/cancer-types/bladder-cancer/types-bladder-cancer Last accessed: August 2026.
- Cancer Australia. 2024. How is bladder cancer diagnosed. [Online] Available at https://www.canceraustralia.gov.au/cancer-types/bladder-cancer/how-bladder-cancer-diagnosed. Last accessed: August 2026
- Powles T, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024;390:875-888
- Cancer Australia. 2024. What are the symptoms of bladder cancer? [Online] Available at https://www.canceraustralia.gov.au/cancer-types/bladder-cancer/what-are-symptoms-bladder-cancer. Last accessed: August 2026
- Cancer Australia. 2024. What are the symptoms of bladder cancer? [Online] Available at https://www.canceraustralia.gov.au/cancer-types/bladder-cancer/what-are-symptoms-bladder-cancer. Last accessed: August 2026
26 August 2026, MAT-AU-PAD-2026-00066