Drug updated on 9/4/2024
Dosage Form | Tablets (oral; 4 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for 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.
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Summary
- Lytgobi (futibatinib [tas-120]) is indicated for 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 summary is based on the review of one randomized controlled trial(s). [1]
- The objective response rate (ORR) was 42% (43 out of 103 patients; 95% confidence interval, 32 to 52) among patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma.
- The median duration of response was 9.7 months, median progression-free survival (PFS) was 9.0 months, and median overall survival (OS) was 21.7 months in the studied population.
- Responses and effectiveness outcomes, including ORR and duration of response, were consistent across various patient subgroups, including those with heavily pretreated disease, older adults, and patients with co-occurring TP53 mutations.
- Common treatment-related Grade 3 adverse events included hyperphosphatemia (30%), increased AST levels (7%), stomatitis (6%), and fatigue (6%).
- Permanent discontinuation due to treatment-related adverse events occurred in 2% of patients, with no treatment-related deaths reported.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lytgobi (futibatinib) Prescribing Information. | 2022 | Taiho Oncology, Inc., Princeton, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma | 6Subjects F: 0% M: 100% | 2023 | The New England Journal Of Medicine |
Sex Distribution:
F:0%
M:100%
6Subjects
Year:
2023
Source:The New England Journal Of Medicine