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NICE recommends AstraZeneca’s combination therapy for NHS use

The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Imfinzi(Durvalumab) in combination with gemcitabine and cisplatin (chemotherapy) for NHS use in England and Wales for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).1

There remains a significant unmet need for new treatment options in BTC, a group of rare and aggressive cancers that occur in the bile ducts and gallbladder, with approximately only 5-15% of patients surviving five years.2,3,5,[7] Worldwide, bile duct cancer, or biliary tract cancer as it is most commonly known, is the second most common primary liver cancer with incidence rates increasing in many western countries, including the UK8,9.

Durvalumab was granted an Innovation Passport in Great Britain based on this specific indication. This means durvalumab was granted intellectual property (IP) and included in the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time it takes innovative treatments to be made available to NHS patients10,11.

Dr Mairéad McNamara, Senior Lecturer (University of Manchester) and Honorary Consultant (The Christie NHS Foundation Trust), Manchester, UK, said: “Following the release of today’s decision by NICE, patients with locally advanced, unresectable, or metastatic biliary tract cancer (who have not received previous treatment for advanced disease), can discuss with their treating oncologists the possibility of accessing a new treatment option (durvalumab in addition to standard of care cisplatin and gemcitabine) that can help to improve outcomes. Results from the TOPAZ-1 trial showed that there were approximately twice as many patients with advanced biliary tract cancer alive at two years following receipt of durvalumab with cisplatin and gemcitabine versus cisplatin and gemcitabine combination alone.”

Helen Morement, Founder and CEO, AMMF – The Cholangiocarcinoma Charity, UK, said: “We are delighted to welcome this decision today from NICE. Cholangiocarcinoma (bile duct cancer), one of the biliary tract cancers, presents many challenges as it can be very difficult to diagnose accurately and early. Most new cases are diagnosed at an advanced stage, and so this recommendation is a huge step forward for people affected who will now have a much-needed new first-line treatment option beyond standard of care chemotherapy alone.”

Tom Keith-Roach, President, AstraZeneca UK, said: “Today’s milestone approval is AstraZeneca’s first in GI cancers in England and Wales. This extremely welcome news supports our ambition to work with NHS partners to challenge treatment expectations for patients with limited treatment options. We are passionate, determined people, working with constructive impatience to make a difference for patients.”

David Brocklehurst, Head of Oncology, AstraZeneca UK, said: “Today’s decision by NICE takes us one step closer to fulfilling our ambition to one day eliminate cancer as a cause of death. Under 15% of patients with biliary tract cancer live for 5-years or more. The need for new treatment options is obvious. We hope that adding an innovative immunotherapy to the treatment options available will play an instrumental role in changing the course for patients.”


1 National Institute for Health and Care Excellence. Final Draft Guidance. Durvalumab with gemcitabine and cisplatin for treating unresectable or advanced biliary tract cancer. Issue date: 23 November 2023.

2 Marcano-Bonilla L, et al. Biliary tract cancers: epidemiology, molecular pathogenesis and genetic risk associations. CCO. 2016;5(5).

3 ESMO. What is Biliary Tract Cancer. Available at: Last accessed: November 2023.

4 Banales JM, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nature Reviews Gastroenterology & Hepatology. 2020; 17: 557-588.

5 Turkes F, et al. Contemporary Tailored Oncology Treatment of Biliary Tract Cancers. Gastroenterol Res Pract. 2019;2019:7698786.

6 Oh D-Y, et al. Updated overall survival from the Phase 3 TOPAZ-1 study of durvalumab or placebo plus gemcitabine and cisplatin in patients with advanced biliary tract cancer. Poster 56P. Presented at the 2022 ESMO Virtual Plenary Session, 16–18 March 2022.

7 Survival for bile duct cancer. Cancer Research UK. Available at: Last accessed: November 2023.

8 Khan SA et al. Rising Trends in Cholangiocarcinoma: is the ICD Classification system misleading us? J Hepatology. 2012;56; 848–854.

9 AMMF – The Cholangiocarcinoma Charity. Introduction to Cholangiocarcinoma. Available at: Last accessed: November 2023.

10 GOV.UK. Innovative Licensing and Access Pathway. Available at: Last accessed: November 2023.

11 GOV.UK. Press release: First Innovation Passport awarded to help support development and access to cutting-edge medicines. Available at: Last accessed: November 2023.


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