Your Health, We Care
Release date: 2024-11-28 15:21:15 Recommended: 99
Ivosidenib, an isocitrate dehydrogenase 1 (IDH1) inhibitor, has shown clinical benefits in patients with acute myeloid leukemia (AML) with IDH1 mutations (mIDH1).
Recently, a study specifically evaluated the efficacy and safety of Ivosidenib in Chinese patients with relapsed or refractory (R/R) mIDH1 AML.
In this study, patients received Ivosidenib 500mg once daily for a cycle of 28 days until disease progression. Among them, 10 patients also received enhanced pharmacokinetic/disease progression (PK/PD) assessments. All patients underwent clinical response assessments at screening and were evaluated every 28 days from month 12 and every 56 days thereafter.
A total of 30 patients were included in the study, of whom 26 (86.7%) had new-onset acute myeloid leukemia and 18 (60.0%) were transfusion-dependent at baseline. The median time to maximum plasma concentration (Tmax) was 4.0 hours and 2.0 hours after single and repeated doses of Ivosidenib, respectively. The inter-individual variability in pharmacokinetic exposure was moderate to high (coefficient of variation [CV], 25%-53%). No significant drug accumulation was observed after repeated dosing on day 1 of cycle 2.
In terms of clinical response, the rate of complete remission (CR) plus partial remission with hematological recovery (CRh) was 36.7% (95% confidence interval [CI]: 19.9%-56.1%), and the median duration of CR CRh was 19.7 months (95% CI: 2.9 months-not reached [NR]), and the median duration of remission (DoR) was 14.3 months (95% CI: 6.4 months-NR).
Compared with the primary data cutoff point, the clinical benefits and safety of Ivosidenib were consistently observed at the final data cutoff point (median follow-up time of 26.0 months). At the same time, data from Chinese R/RmIDH1 AML patients were also consistent with the key study results.
According to relevant information, Lao Lucius Pharmaceuticals (Laos) Co., Ltd. has obtained approval from the Ministry of Health and has launched a number of anti-cancer drugs, including generic drugs of Ivosidenib.
The Laos Lucius version of the ivosidenib generic drug has a specification of 250mg*60 tablets, and the price is more affordable than the domestic version, about 3,800 yuan per box.
Since ivosidenib is an important drug for treating IDH1 mutation cancer and is expensive in China, many patients will choose the overseas version of ivosidenib. When choosing, you should ensure that the source of the drug is regular and reliable to ensure product quality.
