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UK NICE · UK · 21 Aug 2025 · Approval & opinion

Breakthrough life-extending combination treatment for advanced bladder cancer recommended by NICE

AI-generated summary

NICE recommends enfortumab vedotin with pembrolizumab as first-line treatment for adults with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Clinical trials showed the combination nearly doubled progression-free survival to 12.5 months and overall survival to 33.8 months compared to standard chemotherapy. The treatment is available on the NHS from 21 August 2024, with an estimated 1,200 people per year potentially benefiting.

From UK NICE

NICE recommends breakthrough life-extending combination treatment for advanced bladder cancer.

The new treatment offers hope to thousands living with advanced urothelial cancer, with clinical trials showing overall survival rates were almost twice as long compared to standard treatment.

NICE has recommended a new first-line treatment for adults with advanced bladder cancer, marking a significant breakthrough for patients facing this devastating disease.

Enfortumab vedotin (also known as Padcev and made by Astellas) with pembrolizumab (also known as Keytruda and made by MSD) is recommended for treating unresectable or metastatic urothelial cancer for people who are eligible for platinum‑containing chemotherapy.

The combination treatment has been hailed by clinical experts as a ‘step change’ in cancer care, with clinical trial evidence showing it can significantly extend both progression-free survival and overall survival compared to current standard chemotherapy treatments.

The treatment is available in the NHS from today (Thursday, 21 August).

More than 10,000 people are diagnosed with bladder cancer each year in the UK and only around 10% of people with stage 4 bladder cancer will survive five years or more after they are diagnosed.

It is estimated over 1,200 people per year could benefit from this targeted treatment, which is given as an infusion in a clinic or hospital. It is made up of a monoclonal antibody which recognises and kills certain cancer cells.

The standard treatment for unresectable or metastatic urothelial cancer is platinum-based chemotherapy (cisplatin or carboplatin) and a range of other medications.

The recommendation is based on evidence from a clinical trial involving 886 adults with untreated unresectable locally advanced or metastatic urothelial cancer. Progression-free survival almost doubled for people taking enfortumab vedotin and pembrolizumab to 12.5 months compared with 6.3 months for those on chemotherapy and overall survival increased to a median of 33.8 months for those on the combination treatment compared with 15.9 months for those on chemotherapy.

Around 30% of people on the trial achieved a complete remission following treatment with enfortumab vedotin and pembrolizumab, meaning all detectable signs of the disease had disappeared.

Urothelial cancer occurs in the cells that form the inner lining of the bladder and urinary tract, with most cases originating in the bladder. Urothelial cancer accounts for around 90% of all bladder cancers. It is considered metastatic when the cancer has spread outside the pelvis. Unresectable cancer cannot be completely removed by surgery.

In advanced bladder cancer, symptoms may include pelvic or bone pain, unintentional weight loss, swelling in the legs, difficulty urinating, lower back pain, and fatigue.

Excerpt from the official page. The original is authoritative. Continue reading at UK NICE ↗