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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.
“Enfortumab vedotin is an ADC targeting Nectin-4, an adhesion protein located on the surface of epithelial cells including urothelial cancer cells. It is comprised of a fully human IgG1-kappa antibody conjugated to the microtubule-disrupting agent, MMAE, via a protease-cleavable linker.”
“In vitro data indicate that the metabolism of unconjugated MMAE occurs primarily via oxidation by CYP3A4.”
Working under the parallel aged-care framework? Aged-care equivalent →
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.