Lytgobi FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2022.
FDA Approved: Yes (First approved September 30, 2022)
Brand name: Lytgobi
Generic name: futibatinib
Dosage form: Tablets
Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma
Lytgobi (futibatinib) is an irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 for the treatment of intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
- 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. 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).
- Lytgobi works by selectively and irreversibly binding to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.
- Lytgobi is taken orally, once daily.
- Warnings and precautions associated with Lytgobi include ocular toxicity, hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity.
- Common adverse reactions include 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.
Common laboratory abnormalities include increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.
Development timeline for Lytgobi
Further information
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