LYTGOBI futibatinib

Drug Class

Highly selective irreversible FGFR inhibitor

Mechanism

Covalently binds to the kinase domain of FGFR1-4, leading to irreversible inhibition of FGFR phosphorylation and downstream cell growth pathways.

Approved Indication

FDA-approved for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.

What This Means For Patients

LYTGOBI is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2022) — Sources
• EMA — Approved (2023) — Sources

Pivotal Clinical Evidence

• FOENIX-CCA2 — Goyal et al., N Engl J Med 2023 (NCT02052778) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi