Biliary tract cancer and cholangiocarcinoma: US-approved treatments and how Gulf families can access them

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

What is biliary tract cancer?

Bile duct cancer, also called cholangiocarcinoma, is a rare disease in which cancer cells form in the bile ducts. These ducts carry bile from the liver to the gallbladder and small intestine. Intrahepatic bile duct cancer forms in the ducts inside the liver; only a small number of bile duct cancers are of this type. Other bile duct cancers form outside the liver.^[1]

Newer US-approved medicines for advanced disease are matched to the tumor's biology. Each one needs a tumor test first: HER2 for Ziihera, an FGFR2 fusion or rearrangement for Pemazyre and Lyrfigtu, and an IDH1 mutation for Tibsovo. Ask your oncologist whether the tumor has had these tests.^{[2, 3, 4, 5]}

Biliary tract cancer in the Gulf

We did not find published Gulf-specific figures for biliary tract cancer that we could verify, so we do not give any. On 17 October 2026, neither Ziihera nor Lyrfigtu was found in the SFDA drugs list or the Abu Dhabi Department of Health drug code list. We did not check Pemazyre or Tibsovo in those registers.^{[6, 7]}

For a medicine that is not registered, the usual legal route in the Gulf is a request from the treating hospital to the national regulator for one named patient. In Saudi Arabia, the SFDA Special Access Program guidance covers this; in Bahrain, NHRA Circular 41 of 2020 sets the procedure.^{[8, 9]}

US FDA-approved medicines for biliary tract cancer

Each medicine below is approved in the US for a specific group of patients. The wording follows the current US label. Your specialist decides whether any of them is right for the patient.

• Ziihera (zanidatamab-hrii)
  FDA-approved for adults with previously treated biliary tract cancer that cannot be removed by surgery or has spread, when the tumor is HER2-positive (IHC 3+) on an FDA-authorized test (accelerated approval). The label also covers some HER2-positive stomach and esophageal cancers.^{[10, 2]}
  US FDA approval: 20 November 2024. Gulf registers: Saudi Arabia: not found in the SFDA drugs list. Abu Dhabi: not found in the Abu Dhabi DoH drug code list. Checked 17 October 2026. Kuwait, Qatar and Oman: no public register checked.^{[6, 7]}
  Country guides: Saudi Arabia, Bahrain, Iraq, Pakistan
• Pemazyre (pemigatinib)
  FDA-approved for adults with previously treated cholangiocarcinoma that cannot be removed by surgery or has spread, when the tumor has an FGFR2 fusion or other rearrangement on an FDA-approved test (accelerated approval).^[3]
  Current US label version: 9 June 2026. Gulf registers: Not part of our 17 October 2026 Gulf register check. We confirm the status for your country when you ask.
  Country guides: UAE, India
• Lyrfigtu (lirafugratinib)
  FDA-approved for adults with previously treated cholangiocarcinoma that cannot be removed by surgery or has spread, when the tumor has an FGFR2 fusion or other rearrangement (FDA approval summary).^[4]
  US FDA approval: 23 September 2026. Gulf registers: Saudi Arabia: not found in the SFDA drugs list. Abu Dhabi: not found in the Abu Dhabi DoH drug code list. Checked 17 October 2026. Kuwait, Qatar and Oman: no public register checked.^{[6, 7]}
• Tibsovo (ivosidenib)
  FDA-approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with a susceptible IDH1 mutation on an FDA-approved test. The label also covers some blood cancers.^[5]
  Current US label version: 22 December 2025. Gulf registers: Not part of our 17 October 2026 Gulf register check. We confirm the status for your country when you ask.
  Country guides: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman, Egypt, Jordan, Lebanon, India, Pakistan

How families in the Gulf can access these medicines

If it is not registered. The usual legal route is a named-patient request: the treating hospital, on your specialist's written request, asks the national regulator for permission to import the medicine for one patient, using the US FDA approval as the reference. In Saudi Arabia the SFDA Special Access Program guidance covers these requests; in Bahrain, NHRA Circular 41 of 2020 sets the procedure. Other Gulf countries have their own procedures, which the hospital pharmacy confirms.^{[8, 9]} Once approval is in place, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital pharmacy.

Who does what

• Your treating specialist decides whether a medicine is right for the patient and writes the letter.
• The hospital checks local supply, files any import request, and gives the treatment safely.
• The national regulator decides whether to approve the import of a medicine that is not registered.
• The manufacturer decides where its medicine can be supplied, especially for cell and gene therapies.
• Reserve Meds helps organize records, coordinates US supply through our wholesale partner, shipping and updates to your family. We do not give medical advice.

Documents you will usually need

• A letter from the treating specialist with the diagnosis, past treatments and why this medicine is being considered
• Reports that confirm the diagnosis, such as genetic, pathology or laboratory results, translated into English where needed
• Recent clinic notes and a list of current medicines
• For a hospital import request: the prescription, the hospital's request form and the written consent of the patient or guardian
• Proof of the US FDA approval and the US prescribing information (we can supply these)

We give you a written timeline estimate once we see the hospital file. The regulator, the treatment center and the manufacturer set their own timelines.

What treatment costs

Quote on request. Your total cost depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and temperature-controlled shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them.

Sources for the last answer: ^{[2, 3, 4, 5]}

Related

• Digestive system tumors
• Liver cancer (hepatocellular carcinoma)
• Named-patient access in the Gulf, explained
• Answers to common access questions
• Cross-border disclosures
• اقرأ هذه الصفحة بالعربية

This page is general health information, not medical advice. It does not replace a consultation with your doctor.