Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Clinical criteria:

• The condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR

• The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation,

AND

• Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.

AND

• The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.

Treatment criteria:

• Patient must be undergoing treatment with this drug for the first time; OR

• Patient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.