- The approval is based on P-I AG120-C-011 (NCT02074839) study results assessing Tibsovo (ivosidenib, 500mg) in 174 patients with r/r AML and IDH1 mutation aged 67 yrs.
- P-I AG120-C-011 study results: CR+CRh rate 32.8%; CR rate 24.7%; median CR+CRh 8.2 mos.; median time to best response of CR or CRh 2.0mos.; median duration to exposure 3.9mos.; 41/110 (37.3%) patient became independent from RBC or platelet transfusion; 21/174 (12%) are on stem cell transplantation + Tibsovo treatment
- Tibsovo (ivosidenib, 500mg) is a novel PO isocitrate dehydrogenase-1 (IDH1) inhibitor targeted for r/r AML with IDH1 mutation
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