Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• Tibsovo (ivosidenib) is indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed Acute Myeloid Leukemia (AML), either in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. It is also indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with relapsed or refractory AML, for the treatment of adult patients with relapsed or refractory AML, and for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with relapsed or refractory Myelodysplastic Syndromes (MDS) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes. Additionally, it is indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with locally advanced or metastatic cholangiocarcinoma for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• Newly Diagnosed IDH-Mutated AML: CR rate of 47%, ORR rate of 65%, with a 2-year OS rate of 45% and a 2-year EFS rate of 29%.
• Relapsed/Refractory IDH-Mutated AML: CR rate of 21%, ORR rate of 40%, with a median OS of 8.21 months and a median EFS of 4.73 months.
• Ivosidenib and Azacitidine Combination (Phase 3 Trial): EFS HR of 0.33 (95% CI, 0.16 to 0.69; P=0.002), with a 12-month event-free probability of 37% versus 12% (placebo and azacitidine); median OS of 24.0 months versus 7.9 months (placebo and azacitidine), with an HR for death of 0.44 (95% CI, 0.27 to 0.73; P=0.001).
• Gastrointestinal and Hematologic Adverse Events: The most frequent all-grade adverse events were gastrointestinal, while the most frequent ≥ grade 3 adverse events were hematologic.
• Phase 3 Trial Adverse Events: In the Phase 3 trial comparing ivosidenib and azacitidine with placebo and azacitidine, febrile neutropenia occurred in 28% vs. 34%, neutropenia in 27% vs. 16%, bleeding events in 41% vs. 29%, infections in 28% vs. 49%, and differentiation syndrome in 14% vs. 8%.
• There is no population types or subgroups information available in the reviewed studies.