Enfortumab vedotin in combination with pembrolizumab for untreated locally advanced or metastatic urothelial cancer
Cancer
Urological
1 July 2026
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Published on 01 Jul 2026
Last Updated on 01 Jul 2026
Guidance Recommendations
The Ministry of Health’s Drug Advisory Committee has recommended:
Enfortumab vedotin 20 mg and 30 mg powder for concentrate for solution for infusion, in combination with pembrolizumab, for untreated locally advanced or metastatic urothelial cancer.
Funding status
Enfortumab vedotin 20 mg and 30 mg powder for concentrate for solution for infusion are recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 September 2026.
MAF assistance does not apply to pembrolizumab for this indication.
Clinical indication, subsidy class and MediShield Life claims eligibility for enfortumab vedotin are provided in the Annex.
Plain English Summary
Urothelial cancer occurs when cells lining parts of the urinary system such as the bladder, urethra, ureters (tubes that connect the kidneys to the bladder), and the renal pelvis (top part of the ureter), grow abnormally and form a mass (tumour). Common symptoms include blood in the urine and back pain. When the cancer spreads to nearby areas, it is called locally advanced disease. When it spreads to other parts of the body, this is known as advanced or metastatic disease.
Enfortumab vedotin is a type of targeted cancer treatment known as an antibody-drug conjugate. It works by attaching to a protein on the surface of cancer cells and releasing a substance that helps stop the cancer from growing. It is given as a slow drip into a vein (intravenously), usually in combination with another treatment called pembrolizumab.
Enfortumab vedotin was recommended for government funding because its benefit justifies its cost. It is included in the Medication Assistance Fund (MAF) and the treatment cost will be subsidised by 40% to 75% for eligible patients. It can also be claimed under MediShield Life. The subsidy class and MediShield Life claim limits are available here.
