FUTIBATINIB
FUTIBATINIB is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including LYTGOBI. Available dosage form: tablet.
Drug Details
- Generic Name
- FUTIBATINIB
- Brand Names
- LYTGOBI
- Application Number
- NDA214801
- Sponsor
- PENN PHARMACEUTICAL SERVICES LIMITED
- NDC Codes
- 3
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- FUTIBATINIB
Indications and Usage
1 INDICATIONS AND USAGE 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 [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor 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. ( 1 , 2.1 ) 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 )