Astellas secures dual PBS listings for prostate and bladder cancers

Two cancer medicines from Astellas Pharma Australia will be added to the Pharmaceutical Benefits Scheme (PBS) from 1 September 2026, expanding treatment options for patients with bladder and prostate cancers.

The PBS listings cover Padcev (enfortumab vedotin-ejfv), in combination with Keytruda (pembrolizumab), for the first-line treatment of patients with locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, as well as Xtandi (enzalutamide) for non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

Around 3,000 new cases of bladder cancer are diagnosed in Australia each year, with a significant proportion of patients developing metastatic disease. Urothelial cancer is the most common form of bladder cancer.

Padcev, a nectin-4-directed antibody-drug conjugate (ADC) is already PBS listed for patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. However, The expanded PBS listing provides an alternative to platinum-based chemotherapy, which has been the standard first-line treatment for decades.

Evidence from the EV-302 trial demonstrated that the Padcev-Keytruda combination improved both progression-free survival (PFS) and overall survival (OS) by more than 50% compared with standard platinum-based chemotherapy in the first-line treatment of urothelial carcinoma.

Dr Christina Moravski, Head of Medical at Astellas Pharma Australia, said the dual PBS listings reflect Astellas’ commitment to working with government, clinicians and the broader healthcare community to improve patient access to innovative medicines.

“These PBS listings are an important step forward for Australian patients and families affected by urothelial and prostate cancers,” said Dr Moravski. “They also recognise the sustained collaboration required to bring new treatment options through the reimbursement pathway and into clinical practice.”

“At Astellas, our focus is on translating scientific progress into meaningful outcomes for patients,” Dr Moravski added. “Achieving two expanded PBS listings on the same day is a proud moment for our Australian team and a strong example of what can be achieved through partnership, persistence and a shared commitment to patient care.”

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