Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test.

This is written in the approval document as:

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory AML.

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)