Zanidatamab: Cancer Drug Faces NHS Approval Uncertainty Despite Positive Results

A potentially life-extending treatment for a rare and aggressive cancer is facing uncertainty regarding its availability on the National Health Service (NHS) in the United Kingdom. Zanidatamab, a HER2-targeted antibody, offers new hope for patients with cholangiocarcinoma – also known as bile duct cancer – but a final decision on its routine use is still pending, sparking debate about access to innovative cancer therapies.

The National Institute for Health and Care Excellence (NICE) is currently reviewing evidence for zanidatamab. While initial findings suggest the drug is likely to help people live longer and delay their cancer getting worse, NICE officials have stated that significant questions that still require answering remain regarding the extent of its benefit and how it compares to other available treatments. A decision is expected in March 2026.

Cholangiocarcinoma is a relatively uncommon cancer originating in the bile ducts. Treatment options are often limited, and the prognosis can be poor. Zanidatamab works by targeting the HER2 protein, which is present in some cholangiocarcinoma tumors. It represents a new approach to treatment for a subset of patients.

Gareth Honeybone, an NHS surgeon himself, experienced a remarkable response to zanidatamab after initial treatments for his bile duct cancer proved insufficient. Following surgery and chemotherapy for a first tumor, a subsequent tumor was detected. After receiving zanidatamab in combination with standard treatments, scans revealed no evidence of remaining cancer. I’m one of the lucky ones, living a normal life again, thanks to zanidatamab, Honeybone stated. I’m back at work full-time – unlike when I was having chemo and immunotherapy, when I couldn’t work – and I was able to visit my brother in Australia over Christmas. He expressed concern that limited access to the drug could exacerbate existing inequalities in care, with those able to afford private healthcare or participate in clinical trials benefiting from new treatments while others do not.

The case of Huw Jones, a 33-year-old father from Wales, further highlights the urgency surrounding access to zanidatamab. Diagnosed with stage 4 cholangiocarcinoma in 2024 shortly before the birth of his son, Idris, Jones participated in a clinical trial of zanidatamab in January 2025. His family believes the drug significantly improved his condition, shrinking tumors and reducing pain. He sadly passed away in February 2026, but his family continues to advocate for wider access to the treatment. My condition improved a great deal after I started zanidatamab. Some of my tumours shrunk in size, and I was able to reduce the amount of morphine I was taking for pain relief. There are a lot fewer side effects compared to chemotherapy alternatives, I don’t feel as tired and I’m able to continue doing exercise, Jones had said.

The family’s plea has been echoed by cholangiocarcinoma charity AMMF (The Cholangiocarcinoma Foundation), which recognizes the potential of zanidatamab but also acknowledges the challenges NICE faces in evaluating new cancer therapies. Paul Howard, head of policy and research at AMMF, stated that while they recognize NICE’s initial rejection of the drug, they urge a reassessment of the evidence.

NICE’s initial draft guidance rejected the use of zanidatamab for widespread NHS use. The committee’s assessment considered all available evidence, but ultimately determined that a positive recommendation could not be made based on the information submitted by the pharmaceutical company. The upcoming meeting in March will provide an opportunity to review additional data and potentially revise the guidance.

The debate surrounding zanidatamab underscores the complex considerations involved in making new cancer treatments available to patients. Factors such as cost-effectiveness, the severity of the disease, and the potential benefits and risks all play a role in the decision-making process. While zanidatamab shows promise for a subset of patients with cholangiocarcinoma, further evaluation is needed to determine its place in the standard of care.

For patients and families affected by cholangiocarcinoma, the uncertainty surrounding zanidatamab’s availability is understandably distressing. Continued advocacy and research are crucial to ensure that individuals with this aggressive cancer have access to the most effective treatments possible. The outcome of NICE’s review in March 2026 will be closely watched by the cholangiocarcinoma community.