Is ivonib/ivitinib on the market?

Ivosidenib/Ivosidenib is the first isocitrate dehydrogenase-1 (IDH1) inhibitor. IDH1 is an enzyme that is often mutated and overexpressed in some cancers, causing abnormal cell growth and proliferation. Ivonib inhibits mutated IDH1, preventing enzyme activity and further differentiation of cancer cells.

Avosidenib received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2018 for the treatment of relapsed and refractory acute myeloid leukemia in adults. It is also currently approved for the treatment of newly diagnosed acute myeloid leukemia in older adults, in combination with azacitidine or as monotherapy, as well as for the treatment of locally advanced or metastatic cholangiocarcinoma and relapsed or refractory myelodysplastic syndromes in adults. The drug is only effective in patients who are predisposed to IDH1 mutations.

In February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted the positive evaluation of ivonib and recommended that it be granted marketing authorization for the treatment of acute myeloid leukemia and cholangiocarcinoma. For patients with AML, treatment with ivosidenib extended the time they lived before an event occurred (the treatment no longer worked, the cancer came back, or death), as well as their overall survival. In patients with biliary tract cancer, ivosidenib reduced the risk of disease progression. Patients with AML and biliary tract cancers often have a poor prognosis. The side effects of this drug are considered manageable. The known risk of heart rhythm problems is managed by limiting the use of the drug to patients at high risk for these events, and the risk of differentiation syndrome is mitigated by providing educational materials to AML patients. In May 2023, ivonib received full approval from the European Medicines Agency.

In the Chinese market, ivonib was also approved by the National Medical Products Administration on February 9, 2022, and was officially launched for the treatment of adult patients with relapsed or refractory AML carrying IDH1 susceptibility mutations. This approval marks the legal sale and use of ivonib in the Chinese market, providing new treatment hope for Chinese AML patients.