Dr. Javle on the FDA Approval of Infigratinib in FGFR-Mutated Cholangiocarcinoma

Milind Javle, MD, professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the FDA approval of infigratinib (Truseltiq) in cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

On May 28, 2021 the FDA approved infigratinib for the treatment of patients with previously treated locally advanced metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

Prior to the approval, patients with cholangiocarcinoma who progressed on first-line gemcitabine plus cisplatin had limited therapeutic options, says Javle. FOLFOX, the historic standard of care in this setting, is associated with a response rate of about 5%, median progression-free survival (PFS) of about 4 months, and median overall survival of about 6 months, Javle explains.

The approval of infigratinib fulfills a significant unmet need for the subpopulation of patients who harbor FGFR mutations, Javle says. The regulatory decision was based on findings from an ongoing phase 2 clinical trial (NCT02150967) in which infigratinib induced an overall response rate of 23.1%, a median PFS of 7.3 months, and a median duration of response of 5.0 months. Additionally, the disease control rate was very high in this heavily pretreated patient population, concludes Javle.