Regulatory approval

Published by the Food and Drug Administration. Approved

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with 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.

This is written in the approval document.

Citation

Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.

View API

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) IDH1 p.R132C Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132G Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132H Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132L Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132S Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132C Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132G Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132H Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132L Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132S Acute Myeloid Leukemia Azacitidine, Ivosidenib