Lytgobi Receives Accelerated Approval for Cholangiocarcinoma

October 2022, Vol 13, No 5


On September 30, 2022, the FDA accelerated the approval of futibatinib (Lytgobi; Taiho Oncology), a tyrosine kinase inhibitor, for the treatment of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) in adults with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other arrangements. The FDA granted futibatinib a breakthrough therapy designation for this indication.

This approval was based on the efficacy results of the multicenter, open-label, single-arm TAS-120-101 trial that enrolled 103 patients with previously treated, unresectable, locally advanced intrahepatic CCA and an FGFR2 gene fusion or other arrangement.

Patients received 20 mg of futibatinib orally until disease progression or unacceptable toxicity. The main efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by an Independent Review Committee. The ORR was 42% (95% confidence interval [CI], 32-52), with all 43 of the responders achieving a partial response. The median DOR was 9.7 months (95% CI, 7.6-17.1).

The most common (≥20%) adverse events were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

The recommended dose of futibatinib is 20 mg orally once daily until disease progression or unacceptable toxicity.

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