FDA approves futibatinib for cholangiocarcinoma
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The FDA granted accelerated approval to futibatinib for certain patients with cholangiocarcinoma.
The indication applies to use of the agent by adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma who harbor fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Futibatinib (Lytgobi, Taiho Oncology) is a selective FGFR1-4 inhibitor.
The multicenter, open-label, single-arm TAS-120-101 trial assessed the efficacy of futibatinib for 103 patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma who harbor a FGFR2 gene fusion or other rearrangement.
Patients received 20 mg oral futibatinib once daily. Treatment continued until disease progression or unacceptable toxicity.
Overall response rate and duration of response per independent review committee assessment served as the major efficacy outcomes.
Researchers reported an ORR of 42% (95% CI, 32-52). All 43 patients who responded to treatment achieved partial responses. Investigators reported a median response duration of 9.7 months (95% CI, 7.6-17.1).
The most common adverse events included 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 FDA previously granted priority review and breakthrough therapy designation to futibatinib for this indication.
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