Drug updated on 4/18/2024
| 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.
Summary
- Futibatinib (TAS-120), also known as Lytgobi, 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.
- Information about this drug was derived from a single study, which is a Randomized Controlled Trial.
- In terms of effectiveness compared to other treatments for the same condition, futibatinib demonstrated significant antitumor activity in FGFR-altered tumors. It showed consistent responses across several patient subgroups including heavily pretreated patients and older adults.
- The comparison of safety profiles revealed that while futibatinib incurs a notable occurrence of grade 3 adverse events such as hyperphosphatemia and fatigue among others; these were manageable, leading to permanent discontinuation in only 2% of cases, indicating a favorable safety profile with manageable adverse events.
- Quality of life maintenance throughout treatment with futibatinib indicates that despite its side effects, it does not detrimentally affect patient well-being, reflecting an ability not just to prolong life but to maintain its quality as well.
- The assessment is limited by the absence of direct comparative data with other drugs within the same therapeutic domain, necessitating the analysis of additional literature to fully contextualize these findings within the broader treatment landscape for intrahepatic cholangiocarcinoma.
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