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Taiho Oncology Europe announces the launch of Lytgobi®▼ (futibatinib) in the United Kingdom for eligible adult patients with a previously treated subtype of locally advanced or metastatic cholangiocarcinoma1

For United Kingdom (UK) Trade and Medical Media Only

Taiho Oncology Europe GmbH announced today the UK launch of Lytgobi® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor.1,3 This development follows the conditional marketing authorisation (4 September 2024) and subsequent National Institute for Health and Care Excellence (NICE) recommendation (11 September 2024) for futibatinib monotherapy as an option for the treatment of eligible adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.1,4

CCA is an aggressive cancer of the bile ducts that carry bile inside the liver and from the liver and gallbladder to the small intestine. In England, approximately 3,110 people were diagnosed with CCA in 2023,5,6 and the disease is growing in incidence worldwide.7 CCA is usually diagnosed at an advanced stage, with a very poor prognosis with less than one in five patients surviving five years, and there is an unmet need for additional treatment options such as futibatinib.7,8

“Patients with CCA are mostly identified at a late stage of disease and consequently have a poor prognosis. The launch of futibatinib in the UK and positive NICE recommendation for treating locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic treatment in adults represents a much needed additional treatment option for eligible patients with this aggressive cancer,” said Professor John Bridgewater, Clinical Researcher and Medical Oncologist at University College London Cancer Institute and University College London Hospitals NHS Foundation Trust.

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.1 The medicine is taken orally, once daily, on a continuous basis (treatment should be continued until disease progression or unacceptable toxicity).1

The conditional marketing authorisation*, where UK approval is granted for medicines that fulfil an unmet medical need while regulatory data review is ongoing,9 is based on findings from the pivotal Phase 2 FOENIX-CCA2‡ global open-label, single-arm trial evaluating 103 patients with unresectable, locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement.1,10 The trial showed that futibatinib provided a clinically meaningful benefit, meeting its primary endpoint of objective response (partial or complete response as assessed by independent central review) with a rate of 42% (95% CI, 32–52), and a median duration of response of 9.7 months (95% CI, 7.6–17.0).10,11 Among the secondary endpoints, the 12-month overall survival rate was 72% (95% CI, 62–80).10

The most common (≥20%) adverse reactions were hyperphosphatemia (89.7%), nail disorders (44.1%), constipation (37.2%), alopecia (35.2%), diarrhoea (33.8%), dry mouth (31.0%), fatigue (31.0%), nausea (28.3%), dry skin (27.6%), increased AST (26.9%), abdominal pain (24.8%), stomatitis (24.8%), vomiting (23.4%), palmar-plantar erythrodysaesthesia syndrome (22.8%), arthralgia (21.4%), and decreased appetite (20.0%).1

The results of the FOENIX-CCA2 trial were published in The New England Journal of Medicine in 2023.10 Within Europe, eligible patients were enrolled in this trial from France, Germany, Italy, the Netherlands, Spain and the United Kingdom.10

“The launch of futibatinib in the UK is the culmination of extensive and productive collaboration among researchers, healthcare professionals, and patients, all united in their commitment to advance care in cholangiocarcinoma and to improve the lives of eligible patients,” said Dr. Peter Foertig, General Manager of Taiho Oncology Europe. “This marks the first medicine Taiho Oncology has introduced in the UK on our own, signifying our intention to establish a strong presence and reinforcing our ongoing commitment to bringing innovative oral therapies to patients with cancer.”

Futibatinib was developed by Taiho Oncology Europe’s parent company, Taiho Pharmaceutical Co., Ltd., Tokyo. The larger Taiho family of companies continues to investigate its potential in other tumours.12

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

* A conditional marketing authorisation is granted for medicines that fulfil an unmet medical need to treat serious diseases, and the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. As part of this authorisation there will be ongoing review of data to ensure the benefit-risk balance remains positive.9

‡ The FOENIX-CCA2 trial is a Phase 1 / 2 Study of TAS-120 in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: FGFR Oral SElective Novel Inhibitor X [across] tumors.

About Lytgobi (futibatinib) 
Futibatinib is an oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. Futibatinib irreversibly binds to the adenosine triphosphate-binding pocket of FGFR1–4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumour-cell proliferation and increased tumour-cell death in tumours with FGFR1–4 genetic aberrations.1,3

About Taiho Oncology Europe 
The mission of Taiho Oncology Europe is to improve the lives of patients with cancer, their families, and their caregivers. The company specialises in orally administered anti-cancer agents and has a growing pipeline of selectively targeted anti-cancer agents. Taiho Oncology Europe GmbH (Baar, Switzerland) is the European subsidiary of Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan). For more information, visit www.taihooncology.eu.

Lytgobi is a registered trademark of Taiho Pharmaceutical Co., Ltd.

References:

  1. Lytgobi® (futibatinib): Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/100700/smpc#gref Last accessed: November 2025.
  2. Taiho Oncology Europe. Futibatinib in Italy for the treatment of cholangiocarcinoma. Published 12 February 2025. Available at Taiho Oncology Europe Announces Availability of Lytgobi® (futibatinib) in Italy for the Treatment of Cholangiocarcinoma Last accessed: November 2025.
  3. Sootome H, Fujita H, Ito K, et al. Futibatinib is a novel irreversible FGFR 1–4 inhibitor that shows selective anti-tumor activity against FGFR-deregulated tumors. Cancer Res. 2020;80:4986-4997. Available at: https://aacrjournals.org/cancerres/article/80/22/4986/645861/Futibatinib-Is-a-Novel-Irreversible-FGFR-1-4 Last accessed: November 2025.
  4. NICE. Futibatinib for previously treated advanced cholangiocarcinoma with FGFR2 fusion or rearrangement. Published: 11 September 2024. Available at https://www.nice.org.uk/guidance/ta1005 Last accessed: November 2025.
  5. Tataru D, Khan SA, Hill R, et al. Cholangiocarcinoma across England: temporal changes in incidence, survival and routes to diagnosis by region and level of socioeconomic deprivation. JHEP Reports. 2023;6(3):100983. Available at: https://www.jhep-reports.eu/article/S2589-5559(23)00314-2/fulltext Last accessed: November 2025.
  6. Office for National Statistics. Population estimates for the UK, England, Wales, Scotland and Northern Ireland: mid-2023. Available at: Population estimates for the UK, England, Wales, Scotland and Northern Ireland – Office for National Statistics Last accessed: November 2025.
  7. Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557-588. Available at: https://www.nature.com/articles/s41575-020-0310-z#:~:text=CCA%20is%20a%20rare%20cancer,in%20the%20past%20few%20decades Last accessed: November 2025.
  8. Valle JW, Bai LY, Orlova R, et al. Ramucirumab (RAM) or merestinib (MER) or placebo (PL) plus gemcitabine (GEM) and cisplatin (CIS) as first-line treatment for advanced or metastatic biliary tract cancer (BTC): a randomized, double-blind, phase II study. J Clinical Oncol. 2020;38(4):Abstract 477. Available at: https://ascopubs.org/doi/10.1200/JCO.2020.38.4_suppl.477 Last accessed: November 2025.
  9. GOV.UK. Conditional marketing authorisations, exceptional circumstances MAs, scientific advice. Available at: https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice Last accessed: November 2025.
  10. Goyal L, Meric-Bernstam F, Hollebecque A, et al. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2206834 Last accessed: November 2025.
  11. National Library of Medicine. A study of TAS-120 in patients with advanced solid tumors. Available at: https://clinicaltrials.gov/study/NCT02052778 Last accessed: November 2025
  12. National Library of Medicine. Futibatinib search results. Available at: https://clinicaltrials.gov/search?term=Futibatinib%20 Last accessed: November 2025

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Taiho Oncology Europes Lytgobi (futibatinib) launch in UK for advanced cholangiocarcinoma treatment, business news context

Contact

Taiho Oncology Europe Media Contact:
Leigh Labrie
+1 609.664.9878
[email protected]

www.taihooncology.com

Beth Gaffey
+44 7884 318 976
[email protected]

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