Patients with advanced bile duct cancer who hope to use the newly approved drug lirafugratinib must first have tumor testing that confirms an FGFR2 gene fusion or rearrangement, and the drug's label states that no FDA-authorized test for that purpose is available. The FDA approved lirafugratinib, sold as Lyrfigtu, on Sept. 23 for adults whose cholangiocarcinoma was previously treated and cannot be removed by surgery.
That gap puts more responsibility on patients and their oncologists, who must make sure the right test is done. The label also calls for regular eye exams during treatment, because changes in the retina were common in studies.
