What is the detailed information about Avonib Tablets?

Ivosidenib/Ivosidenib (Ivosidenib) is a targeted small molecule drug that specifically targets isocitrate dehydrogenase 1 (IDH1) gene mutations. It was first approved by the United States in 2018. It is approved by DA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who carry IDH1 mutations, and will be further approved in 2021 for the treatment of patients with locally advanced or metastatic cholangiocarcinoma (CCA) who are positive for IDH1 mutations. Ivonib specifically inhibits the mutant IDH1 enzyme, reduces the excessive production of 2-hydroxyglutarate (2-HG) in tumor cells, restores normal cell differentiation, and thereby inhibits tumor growth.

The recommended dose is 500 mg once daily, with treatment continued until disease progression or unacceptable toxicity. Common side effects include differentiation syndrome, QT interval prolongation, leukocytosis, fatigue, nausea and diarrhea, etc. Therefore, ECG changes and hematological indicators need to be closely monitored during treatment. The launch of ivonib has greatly promoted the personalized treatment of cancers related to IDH1 mutations, especially in the field of cholangiocarcinoma where chemotherapy is ineffective, providing patients with new treatment options.

It is worth noting that molecular testing is required before using ivonib to confirmIDH1 gene mutation status, which is also an important prerequisite for precise medication. Clinical research data shows that in patients with cholangiocarcinoma, ivonib can significantly prolong progression-free survival (PFS) and overall survival (OS) and help improve quality of life. At present, ivonib has been approved for marketing in many countries around the world, including the United States, Japan, and the European Union. Domestic imported original drugs have also been gradually introduced. However, due to the short time to market, limited medical insurance coverage, and relatively high drug prices, patients need to combine doctor's guidance and a comprehensive assessment of their economic status when taking the drug.

Reference: https://www.tibsovo.com/