PBS listing covers first-line bladder cancer care
PADCEV in combination with pembrolizumab has been added to the Pharmaceutical Benefits Scheme for first-line treatment of locally advanced or metastatic urothelial cancer from 1 September 2026.
Astellas Pharma Australia announced the listing in Sydney on 1 September 2026. PADCEV is the brand name for enfortumab vedotin.
Urothelial cancer starts in the inner lining of the bladder wall, known as urothelial cells. It can grow into the outer muscle wall of the bladder or spread to other parts of the body.
Doctors describe the disease as locally advanced when it has spread into surrounding tissues or organs. They call it metastatic when it has spread to more distant parts of the body.
Chemotherapy has been the main treatment for urothelial cancer that has spread outside the bladder for the past 40 years, according to Astellas.
Cancer Australia data cited by the company shows an estimated 3,345 Australians were diagnosed with bladder cancer in 2025. About 80% to 90% of those cases were likely to be urothelial cancers.
Five-year survival fell to 57%
Bladder cancer survival in Australia has worsened over the past 30 to 40 years, according to Cancer Australia data cited by Astellas. In the late 1980s, nearly two in three people, or 66%, were expected to be alive five years after diagnosis.
By 2017, the average five-year survival rate had dropped to 57%. Astellas linked the PBS listing to the need for new treatment options.
Associate Professor Andrew Weickhardt, a medical oncologist who focuses on genitourinary cancers, said effective new first-line treatment approaches for locally advanced and metastatic urothelial cancer had been long awaited.
He said the PBS listing marked a major change from relying only on chemotherapy in first-line treatment for these patients. He also pointed to advances in drug design and large clinical trials.
Meanwhile, BEAT Bladder Cancer Australia CEO Adam Lynch urged people to act quickly on possible symptoms. He said bladder cancer had not received the same level of attention or investment as many other cancers.
Lynch said that lack of awareness meant many people did not know what to look for. He warned that symptoms can be easy to dismiss or hard to talk about, which can delay people seeking help.
The company did not give PBS pricing details or say how many patients are expected to receive the combination treatment.
