LYTGOBI

What it is

LYTGOBI is a film-coated tablet containing 4 mg of futibatinib. Futibatinib is a tyrosine kinase inhibitor that irreversibly inhibits FGFR 1, 2, 3, and 4 by covalent binding. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy in adult patients (monotherapy with provisional approval).

Dosing overview

The recommended starting dose is 20 mg futibatinib taken orally once daily. The tablets should be taken with or without food at about the same time each day and should be swallowed whole to ensure that the full dose is administered. Treatment should be continued until disease progression or unacceptable toxicity. LYTGOBI therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. Presence of FGFR2 gene fusions or rearrangements should be confirmed by an appropriate diagnostic test prior to initiation of LYTGOBI therapy.

Key safety warnings

Hyperphosphataemia is a pharmacodynamic effect expected with futibatinib administration. Prolonged hyperphosphataemia may cause soft tissue mineralisation, including cutaneous calcification, vascular calcification, and myocardial calcification, anaemia, hyperparathyroidism, and hypocalcaemia that may cause muscle cramps, QT interval prolongation, and arrythmias. In all patients, dietary restrictions that limit phosphate intake are recommended as part of hyperphosphataemia management. A phosphate-lowering therapy should be initiated when serum phosphate level is ≥ 5.5 mg/dL. Futibatinib can cause serous retinal detachment, which may present with symptoms such as blurred vision, visual floaters, or photopsia. A comprehensive ophthalmological examination, including optical coherence tomography (OCT) of the macula, should be performed prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. Based on the mechanism of action and findings in an animal study, futibatinib can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the fetus. An effective method of contraception should be used in women of childbearing potential and in men with women partners of childbearing potential during treatment with LYTGOBI and for 1 week following completion of therapy, barrier methods should be applied as a second form of contraception to avoid pregnancy.

Contraindications

LYTGOBI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Regulatory history

LYTGOBI futibatinib 4 mg tablet was first listed on the ARTG on 17 April 2025. The AusPAR approval date was 10 April 2025. The decision to approve this indication was made on the basis of the favourable objective response rate and duration of response in a single arm trial. The decision to approve this indication has been made on the basis of the favourable objective response rate and duration of response in a single arm trial. Continued approval of this indication depends on verification and description of benefit in confirmatory trials. PBAC recommended not approving LYTGOBI in March 2025, and this recommendation was reiterated in July 2025.