Initial US Approval
20221
Indications
The treatment of adult patients with previously treated, unresectable, locally advanced or metastatic, intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Recommended Dose/Route
Futibatinib, 20 mg (five 4-mg tablets), taken orally once daily with or without food.1
Pivotal Studies
TAS-120-101 (NCT02052778)2
Key Inclusion Criteria: 103 patients with previously treated, unresectable, locally advanced or metastatic, intrahepatic cholangiocarcinoma with identified FGFR2 fusions or other rearrangements as determined using next-generation sequencing.2
Treatment
Futibatinib, 20 mg, orally once daily until disease progression or unacceptable toxicity occurred.2
Safety
The most common any-grade adverse events (AEs) were nail toxicity (47%), musculoskeletal pain (43%), constipation (39%), diarrhea (39%), fatigue (37%), dry mouth (35%), alopecia (34%), stomatitis (30%), abdominal pain (30%), dry skin (29%), arthralgia (25%), dysgeusia (25%), and dry eye (25%).1 The most any-grade common laboratory abnormalities were increased phosphate (97%), increased creatinine (58%), decreased hemoglobin (52%), increased glucose (52%), increased calcium (51%), decreased sodium (51%), decreased phosphate (50%), increased alanine aminotransferase (50%), increased alkaline phosphatase (47%), decreased lymphocyte (46%), increased aspartate aminotransferase (46%), decreased platelets (42%), and increased activated partial thromboplastin time (36%).1
Dosage interruptions due to AEs: 66%1
Dosage reductions due to AEs: 58%1
Permanent discontinuation due to AEs: 4.9%1
References
- Lytgobi. Prescribing information. Taiho Oncology; 2023. Accessed April 10, 2024. https://taihocorp-media-release.s3.us-west-2.amazonaws.com/documents/LYTGOBI_Prescribing_Information.pdf
- Goyal L, Meric-Bernstam F, Hollebecque A, et al; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med. 2023;388(3):228-239. doi:10.1056/NEJMoa2206834