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Agency for Care Effectiveness
Drug guidance

Enfortumab vedotin in combination with pembrolizumab for untreated locally advanced or metastatic urothelial cancer

5 October 2026

Condition

Cancer

Urological

-

Published on 01 Jul 2026
Last Updated on 05 Oct 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.

Pembrolizumab 100 mg/4 mL solution for infusion is recommended for inclusion on the MAF for the abovementioned indication from 1 December 2026

Clinical indication, subsidy class and MediShield Life claims eligibility for enfortumab vedotin and pembrolizumab are provided in the Annex.

Enfortumab vedotin in combination with pembrolizumab for untreated locally advanced or metastatic urothelial cancer (Updated 05 Oct 2026) [PDF, 283.58 KB] (opens in new tab)

Plain English Summary

Urothelial cancer occurs when cells lining the bladder or other parts of the urinary system such as the urethra, ureters (tubes that connect the kidneys to the bladder), or the renal pelvis (the area where urine collects before passing into the ureter) grow abnormally and form a mass (tumour). Common symptoms include blood in the urine and back pain. If the cancer spreads to nearby areas, it is called locally advanced disease. If it spreads to other parts of the body, it is called advanced or metastatic disease.

Enfortumab vedotin is a targeted cancer treatment known as an antibody-drug conjugate. It attaches to a protein on cancer cells and delivers 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.

Pembrolizumab belongs to a group of medicines called PD-1/PD-L1 checkpoint inhibitors which are a type of immunotherapy. It helps the body’s immune system find and attack cancer cells. It is also given as a slow drip into a vein (intravenously).

Enfortumab vedotin, in combination with pembrolizumab, was recommended for government funding because its benefits justify its cost. The medicines are included in the Medication Assistance Fund (MAF) (opens in new tab), with their costs subsidised by 40% to 75% for eligible patients. They can also be claimed under MediShield Life. The subsidy class and MediShield Life claim limits are available here (opens in new tab).