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

YTGOBI is an irreversible selective FGFR kinase inhibitor. Approved by the FDA and EMA for previously treated intrahepatic cholangiocarcinoma, it is accessible for clinical use under Hainan pilot-zone regulations.

Regulatory Approvals

• FDA — approved (2022) — label
• EMA — approved (2023) — source

Pivotal Clinical Evidence

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

Sources

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