Ivosidenib Tablets

Ivosidenib (trade name Tosuvo® [4]) is the first approved drug in China [4], a potent oral targeted inhibitor for isocitrate dehydrogenase-1 (IDH1) mutant cancers [2]. Originally developed by Agios Pharmaceuticals, CStone Pharmaceuticals and Agios reached an exclusive development and commercialization agreement in Greater China in 2018, and expanded its clinical development and commercialization authorization area from Greater China to Singapore in 2020. [3]
On February 9, 2022, the China National Medical Products Administration (NMPA) approved the new drug application for ivosidenib, a first-in-class drug [6]. The drug is the first IDH1 inhibitor approved in China, used to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying IDH1 susceptible mutations. [4]
Ivosidenib has been approved by the US FDA for three indications:
①, for the monotherapy of adult patients with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations;
②, for combination with azacitidine for newly diagnosed acute myeloid leukemia with susceptible IDH1 mutations detected by an FDA-approved test in adults aged 75 years or older, or patients with comorbidities that preclude the use of intensive induction chemotherapy [7];
③, for previously treated adult patients with locally advanced or metastatic cholangiocarcinoma with IDH1 mutations detected by an FDA-approved test