Biliary Tract Cancers: Latest Developments

Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in biliary tract cancers. For general information about the disease, see the Biliary Tract Cancers page.

• • Promising Studies
  • Congress · ESMO 2026
  • Biliary Tract Cancer
  • 24 October 2026

  Gemcitabine + cisplatin compared with capecitabine after surgery for biliary tract cancer: results favourable but the primary analysis was borderline (ACTICCA-1)

  In bile duct (cholangiocarcinoma) and gallbladder cancer, recurrence can occur within two years in about half of patients even after surgery; the treatment widely used after surgery today is oral capecitabine. In the phase 3 ACTICCA-1 trial, conducted in Europe and Australia and funded independently of the pharmaceutical industry, 591 patients received gemcitabine + cisplatin or capecitabine for 24 weeks after surgery. At about 5 years of follow-up, median time without recurrence was 2.14 years with gemcitabine + cisplatin and 1.49 years with capecitabine; however, the trial’s main statistical test did not reach the significance threshold. A prespecified additional analysis showed an average of about 2.6 months longer disease-free time over the first 3 years with gemcitabine + cisplatin. There was a favourable trend in survival, but the difference was not significant. Serious side effects were slightly more frequent with gemcitabine + cisplatin. These results suggest there may be one more option when choosing treatment after surgery, but they do not show clear superiority. The decision on post-surgery treatment in biliary tract cancer requires joint assessment by medical oncology, hepatobiliary surgery, gastroenterology, radiology and pathology.

  These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

  Status in Turkey: Products containing gemcitabine, cisplatin and capecitabine are on the TİTCK list of licensed products dated 16.10.2026 and on the SGK EK-4/A list dated 23.10.2026. The reimbursement scope of gemcitabine + cisplatin after surgery for biliary tract cancer could not be verified.

  • Source:
  • ESMO Congress 2026, LBA21 abstract
  • ESMO list of simultaneous publications (27 October 2026)
• • FDA Approval
  • Biliary Tract Cancer
  • 23 September 2026

  Lirafugratinib received FDA approval for cholangiocarcinoma with an FGFR2 fusion

  The FDA approved lirafugratinib, a kinase inhibitor, for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (biliary tract cancer) with an FGFR2 gene fusion or other rearrangement. The assessment is based on the single-arm, open-label REFOCUS trial in 116 patients who had not previously received an FGFR inhibitor and had received chemotherapy or chemo-immunotherapy. The objective response rate assessed by an independent committee according to RECIST v1.1 was 46% (95% confidence interval 36–55) and the median duration of response 11.8 months (95% confidence interval 7.5–13.0). The label includes warnings for ocular toxicity, hyperphosphataemia and soft tissue mineralisation, and for embryo-fetal toxicity. The FDA reviewed the application under priority review.

  Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with lirafugratinib.

  • Source:
  • FDA announcement (23 September 2026)
  • REFOCUS trial, ClinicalTrials.gov NCT04526106
  • TİTCK List of Licensed Human Medicinal Products
• • FDA Approval
  • Biliary Tract Cancer
  • 8 May 2026

  Zenocutuzumab receives FDA approval in cholangiocarcinoma with an NRG1 fusion

  The FDA approved zenocutuzumab for adults with advanced, unresectable or metastatic cholangiocarcinoma carrying an NRG1 (neuregulin 1) gene fusion whose disease progressed during or after systemic therapy. The FDA describes NRG1-fusion cholangiocarcinoma as an extremely rare and life-threatening disease. The assessment is based on the cholangiocarcinoma cohort of the multi-cohort, open-label eNRGy trial in adults with advanced solid tumours: 22 patients were enrolled and 19 were evaluated for efficacy; the confirmed objective response rate was 36.8% (95% confidence interval 16.3–61.6) and the duration of response ranged from 2.8 to 12.9 months. Because the number of patients is very small, these results should be interpreted with caution. The label includes warnings for infusion-related reactions, hypersensitivity and anaphylaxis, interstitial lung disease or pneumonitis, left ventricular dysfunction and embryo-fetal toxicity.

  Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with zenocutuzumab.

  • Source:
  • FDA announcement (8 May 2026)
  • eNRGy trial, ClinicalTrials.gov NCT02912949
  • TİTCK List of Licensed Human Medicinal Products

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The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.