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More than 2,000 patients in England could benefit from an endometrial cancer treatment available immediately that could slow cancer progression in patients with advanced womb cancer, the National Institute for Health and Care Excellence (NICE) has announced.
In final draft guidance, published on 6 August 2025, NICE has approved the immunotherapy drug pembrolizumab (Keytruda: Merck Sharp and Dohme) to be added to chemotherapy (carboplatin and paclitaxel) on the NHS, potentially benefiting around 2,100 people with previously untreated primary advanced or recurrent endometrial cancer, according to NICE.
Under the Cancer Drugs Fund, which funds cancer drugs from first approval rather than waiting for final appraisal, the treatment has been made available “immediately”, following a commercial arrangement between Merck Sharp and Dohme and the NHS.
The guidance is based on evidence from an ongoing phase III, global, double-blind trial — KEYNOTE-868 (NRG-GY018) — which found that adding pembrolizumab to carboplatin and paclitaxel increases the time before patients’ condition worsens compared with platinum-based chemotherapy alone.
Patient experts told NICE that people with endometrial cancer often experience a sense of helplessness on platinum-based chemotherapy because it is not associated with curing endometrial cancer.
Even though adding immunotherapy to platinum-based chemotherapy could increase side effects, they added that patients would be willing to accept this if it prolonged response and if it potentially avoided the need for further treatment.
Results from the trial suggested that pembrolizumab with carboplatin and paclitaxel then pembrolizumab maintenance was significantly more effective — with a 70% difference in relative risk — at preventing progression or death than carboplatin and paclitaxel alone.
However, the clinical trial is ongoing, meaning that evidence around the treatment’s impact on long-term mortality is less certain.
The NICE guidance states that the treatment should be stopped after two years, or earlier if there is disease progression or unacceptable toxicity.
Andrew Walker, gynaecology specialist pharmacist and executive committee member of the British Oncology Pharmacy Association, said: “This decision by NICE represents a significant positive development for patient care and helps to address the unmet need for additional first-line treatment options to improve outcomes for patients with advanced endometrial cancer. The strength of clinical evidence presented to NICE from the keynote trial highlights the benefit of this treatment option.
“Specialist oncology pharmacists working alongside medical colleagues are well placed to ensure patients receive safe and effective treatment using this combination of chemotherapy and pembrolizumab,” he added.
Helen Hyndman, lead nurse at gynaecological cancer charity the Eve Appeal, commented: “Primary advanced or recurrent womb (endometrial) cancer has a huge impact on the quality of life for those diagnosed. It is great news that this new treatment has been approved. It will offer hope, a better quality of life and improve outcomes for those affected.”
Anthony Cunliffe, lead medical adviser at Macmillan Cancer Support, said this was a “hugely exciting step” and a “brilliant example of how the UK could become one of the best countries in the world when it comes to cancer care if governments across the UK take urgent action”.
