AstraZeneca’s Imfinzi gains UK NHS approval for stomach cancer after NICE green light

UK—UK patients with aggressive stomach cancer now have access to their first immunotherapy treatment after the National Institute of Health and Care Excellence (NICE) recommended AstraZeneca’s Imfinzi (durvalumab) for the National Health Service.

The regulatory approval marks a major milestone in cancer care, as approximately 1,500 people diagnosed annually in England with this aggressive form of stomach cancer will benefit from the new treatment.

NICE recommended Imfinzi for adults whose stomach cancer has not spread extensively and can be removed through surgery, including gastric and gastro-oesophageal junction cancers that physicians frequently diagnose at advanced stages.

The treatment will be administered in combination with chemotherapy before surgery to shrink tumours, followed by continued use afterward to help prevent recurrence.

Breakthrough clinical trial results drive approval

Data from AstraZeneca’s MATTERHORN Phase III trial demonstrated that patients receiving Imfinzi combined with standard-of-care FLOT chemotherapy (fluorouracil, leucivorin, oxaliplatin, and docetaxel) achieved significant improvement in event-free survival, the study’s primary endpoint.

This perioperative regimen, given before and after surgery, followed by Imfinzi alone, extends both the time before cancer progresses and overall survival compared with chemotherapy alone.

In the final overall survival analysis, the Imfinzi and FLOT perioperative regimen reduced the risk of death by 22% compared with chemotherapy alone.

Approximately 69% of patients treated with the Imfinzi-based regimen remained alive at three years, compared with 62% in the FLOT-only arm. Notably, this survival benefit occurred regardless of tumour PD-L1 status.

How Imfinzi Works and global impact

Imfinzi works by blocking the PD-L1 protein on cancer cells, which normally acts as a pro-tumorigenic factor, thereby allowing the body’s immune system to evade cancer.

As a monoclonal antibody, Imfinzi enables T-cells to identify and destroy tumour cells effectively. The drug is administered intravenously every four weeks.

Gastric cancer ranks as the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.

The UK sees around 7,000 new stomach cancer cases annually, and while incidence rates decrease, prognosis remains poor, with only 16% of UK patients surviving ten years or more.

Streamlined approval process and recent financial performance

Imfinzi represents one of the first drugs to travel through a new aligned pathway between NICE and the Medicines and Healthcare products Regulatory Agency (MHRA), with the NHS recommendation coming just 17 days after marketing authorization.

Helen Knight, NICE’s director of medicines evaluation, stated that streamlined processes will benefit thousands of people with this aggressive cancer while providing value to taxpayers.

Imfinzi ranked as AstraZeneca’s second-best-selling drug in 2025, generating US$6 billion globally, up 29% from 2024, driven by new launches in bladder and lung cancer.

AstraZeneca reported Q1 2026 total revenue of $15.3 billion, up 8%, driven by double-digit oncology growth.