TGA nod marks major shift in clinical management of bladder cancer after decades

The Therapeutic Goods Administration (TGA) has approved Astellas’ Padcev (enfortumab vedotin) in combination with MSD’s Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced or metastatic urothelial (bladder) cancer.

This marks a major shift in the treatment landscape, as the combination therapy becomes the first approved alternative to platinum-containing chemotherapy, which was the standard of care for decades. In fact, the ESMO Clinical Practice Guidelines now recommend the Padcev combination as the “new standard of care in first-line advanced urothelial carcinoma”.

Nirelle Tolstoshev, General Manager at Astellas Australia, stated “As the most significant new treatment option for advanced bladder cancer in decades, the TGA’s registration of Padcev in combination with pembrolizumab marks an important milestone for Australians affected by this disease.”

Clinical data from the EV-302 phase 3 study demonstrated a 53% reduction in the risk of death with Padcev combination therapy compared to chemotherapy in previously untreated bladder cancer patients (median overall survival: 31.5 months vs. 16.1 months; p<0.00001). The combination therapy also significantly improved progression-free survival (PFS), cutting the risk of disease progression or death by 55% (median PFS: 12.5 months vs. 6.3 months; p<0.00001).

Tolstoshev added, “Following a positive PBAC recommendation in November, Astellas is now focused on working with government to make this innovative first-line treatment accessible to patients as quickly as possible.”

The PBAC acknowledged that the Padcev combination therapy provides a significant efficacy improvement over platinum-based chemotherapy with gemcitabine for some patients. The committee’s recommendation for listing was contingent on a risk-sharing arrangement that accounts for expenditure across both first-line and subsequent-line therapies.

The TGA approval aligns with global regulatory momentum, following the European Commission’s approval of Padcev (owned by Astellas and Pfizer) in August 2024 and the U.S. FDA’s approval in December 2023.

With approximately 3,000 Australians diagnosed with bladder cancer each year and a significant number developing metastatic disease, this approval represents a critical advancement in treatment options for patients facing this aggressive cancer.

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