Futibatinib(LYTGOBI)
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LYTGOBI (futibatinib) is a targeted kinase inhibitor designed for the treatment of patients with specific genetic alterations in their tumors, particularly FGFR2 gene fusions or rearrangements. It is administered orally as a 4 mg tablet, with the recommended dose being 20 mg (five 4 mg tablets) taken once daily. This therapy is specifically aimed at addressing the needs of patients with advanced intrahepatic cholangiocarcinoma who have failed previous treatment options.
The drug operates by inhibiting fibroblast growth factor receptor 2 (FGFR2), a protein involved in tumor growth and progression. By targeting this pathway, LYTGOBI aims to reduce tumor size and prevent further disease progression. The clinical use of LYTGOBI requires confirmation of the presence of FGFR2 gene alterations prior to starting therapy, and treatment should be continued until disease progression or unacceptable toxicity occurs. Ongoing monitoring for ocular toxicity and other side effects is crucial for ensuring patient safety during treatment.
Generic name
Futibatinib(LYTGOBI)
Alternative Names
LYTGOBI
Indications
LYTGOBI (futibatinib) is indicated for the treatment of adult patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under the accelerated approval pathway based on overall response rate and duration of response. Continued approval for this indication may be contingent upon the results of confirmatory trials.
Active Ingredients
futibatinib
specifications
4 mg per tablet
Description
LYTGOBI (futibatinib) is an oral selective inhibitor of fibroblast growth factor receptor (FGFR) 2, a protein involved in the regulation of cell growth and angiogenesis. It is specifically indicated for use in adult patients with FGFR2 gene fusions or rearrangements who have advanced or metastatic intrahepatic cholangiocarcinoma. The drug works by blocking the activation of FGFR2, thereby inhibiting the downstream signaling pathways involved in tumor cell proliferation and survival.
Dosage and Administration
Dosage: The recommended dosage of LYTGOBI is 20 mg orally once daily. This corresponds to five 4 mg tablets taken together.
Administration: LYTGOBI should be swallowed whole with or without food.
Duration: Continue treatment until disease progression or the occurrence of unacceptable toxicity.
Pre-treatment Testing: Prior to initiating treatment with LYTGOBI, confirm the presence of an FGFR2 gene fusion or rearrangement through appropriate genetic testing.
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