New treatment option on the PBS for locally advanced or metastatic bladder cancer

in combination with pembrolizumab has been added to the Pharmaceutical Benefits Scheme for first-line (initial) treatment of locally advanced and metastatic bladder cancers¹

SYDNEY, 1 September 2026 – Astellas Pharma Australia Pty Ltd today announced PADCEV^TM (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.