LYRFIGTU (Lirafugratinib)

LYRFIGTU (lirafugratinib) is an oral targeted cancer medicine approved by the US FDA on 23 September 2026 for adults with previously treated cholangiocarcinoma (bile duct cancer) that cannot be removed by surgery or has spread, and whose tumour carries an FGFR2 fusion or other FGFR2 rearrangement.

Lirafugratinib is a kinase inhibitor that binds covalently to FGFR2 and shuts down the growth signals it sends inside the cancer cell. Because it targets one specific genetic change, the FGFR2 alteration has to be confirmed in tumour tissue before treatment starts. The label notes that no FDA-authorised companion test was available at approval.

In the single-arm REFOCUS study, 116 patients who had already received platinum-based treatment, but no earlier FGFR inhibitor, were treated. Tumours shrank in 46% of patients (3 complete and 50 partial responses), and the median duration of response was 11.8 months. The FDA granted priority review, orphan drug status and Breakthrough Therapy designation.

Other medicines for biliary tract cancer that we help patients source include Ziihera (zanidatamab), which is used for HER2-positive disease.

• Eye checks are essential. Fluid under the retina (retinal pigment epithelial detachment) occurred in 31% of patients, usually about 2 months after starting. An eye examination with OCT scanning is needed before treatment, every 2 months for the first 13 months and every 4 months after that, and urgently if vision becomes blurred. Dry eye (38%) and corneal irritation (11%) are also common.
• High blood phosphate was reported in 21% of patients and can lead to calcium deposits in soft tissues; phosphate levels are monitored throughout treatment.
• It can harm an unborn baby. Women should use contraception during treatment and for 6 months after the last dose, men for 3 months, and breastfeeding should stop until 1 week after the last dose. It may also affect male fertility.
• In REFOCUS the most frequent side effects were nail changes (89%), hand-foot syndrome (82%), mouth sores (80%), hair loss (66%), dry eye (53%), dry mouth (50%) and tiredness (43%). Dose interruptions (88%) and reductions (81%) were common, and only 5% of patients stopped for side effects.
• Strong or moderate CYP3A inhibitors raise lirafugratinib levels; they are best avoided, otherwise the dose is reduced to 40 mg or 50 mg. CYP3A inducers should be avoided. Lirafugratinib can raise levels of medicines handled by P-gp, BCRP, OATP1B1 and OATP1B3.
• Sensitivity to sunlight is possible, so sun protection is advised.

Which patients is LYRFIGTU meant for?

Adults with bile duct cancer that is advanced or cannot be operated on, who have already had at least one earlier treatment and whose tumour test shows an FGFR2 fusion or rearrangement. The treating medical oncologist confirms suitability.

Which documents should be sent?

• Oncologist’s prescription stating the daily dose (70 mg is the starting dose)
• Molecular or NGS report showing the FGFR2 fusion or rearrangement
• Recent treatment summary listing earlier therapies
• Patient’s photo ID

Why are there five different cartons?

Each DosePak carton matches one daily dose (70, 50, 40, 30 or 20 mg) using a combination of 20 mg and 30 mg capsules. If the oncologist lowers the dose because of side effects, a different carton is ordered, so please tell us the current dose before every order.

How is it stored and how long does it last?

Store at 20–25 °C (brief periods between 15 and 30 °C are fine). The approval letter allows a shelf life of 36 months from manufacture, so it travels without refrigeration.

Is LYRFIGTU available in India?

Not as a registered product; CDSCO has not approved it. It can be imported on a named-patient basis with the oncologist’s prescription and the FGFR2 test report.

In the USA, LYRFIGTU is distributed by Elevar Therapeutics. We check supply with the authorised distributor before quoting, import it in the patient’s name, and share the dispatch and delivery timeline before payment is taken.

For LYRFIGTU price in India and availability for a specific dose: Call +91 96548 60915, WhatsApp +91 93100 90915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA approval on 23 September 2026 (NDA 220425; new molecular entity, priority review, orphan drug, Breakthrough Therapy).
• European Union and Japan: Not approved as of October 2026.
• India: Not approved by CDSCO.

Sources:

• LYRFIGTU US Prescribing Information (FDA, September 2026)
• FDA approval letter, NDA 220425
• Drugs@FDA record for NDA 220425
• FDA: approval of lirafugratinib for FGFR2-altered cholangiocarcinoma

Information last checked: October 2026.

What is LYRFIGTU used for?

Treating adults with previously treated, advanced cholangiocarcinoma whose tumour has an FGFR2 fusion or other FGFR2 rearrangement.

What is the usual dose of lirafugratinib?

70 mg by mouth once a day, with or without food, swallowed whole. Lower steps of 50, 40, 30 and 20 mg are used if side effects need managing.

What if a dose is missed?

It can be taken if fewer than 4 hours have passed; otherwise skip it and take the next dose at the usual time. Do not repeat a dose after vomiting.

Why are eye tests needed on lirafugratinib?

Because it can cause fluid to collect under the retina, which may blur vision. Regular OCT eye scans pick this up early so the dose can be adjusted.

Who makes LYRFIGTU?

Elevar Therapeutics, Inc. of Fort Lee, New Jersey, holds the US approval and distributes it.

Is LYRFIGTU approved by the FDA?

Yes, since 23 September 2026.