On September 30, 2022, the FDA approved Lytgobi (futibatinib; from Taiho Oncology), a tyrosine kinase inhibitor (a targeted therapy), for the treatment of adults with unresectable (can’t be removed by surgery), locally advanced or metastatic (spreading) intrahepatic cholangiocarcinoma (a type of gastrointestinal [GI] cancer) associated with an FGFR2 gene fusion or other rearrangements.
“Lytgobi is a key example of the potential of precision medicine in [cholangiocarcinoma] and represents another advance in the treatment of this rare and challenging disease,” said Lipika Goyal, MD, MPhil, of Massachusetts General Hospital Cancer Center.
The FDA approved Lytgobi for cholangiocarcinoma based on results of a multicenter clinical trial that included 103 patients with unresectable, locally advanced, intrahepatic cholangiocarcinoma associated with the FGFR2 biomarker.
Of the 103 patients in the study, 43 (42%) had a partial response to Lytgobi, and the average duration of response was 9.7 months.
The most common side effects reported in 20% or more of patients using Lytgobi are nail problems, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, hair loss, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
