Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to ivosidenib as a monotherapy or in combination with azacitidine for the treatment of adult patients newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
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 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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | IDH1 p.R132C | Acute Myeloid Leukemia | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132G | Acute Myeloid Leukemia | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132H | Acute Myeloid Leukemia | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132L | Acute Myeloid Leukemia | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132S | Acute Myeloid Leukemia | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132C | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132G | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132H | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132L | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132S | Acute Myeloid Leukemia | Azacitidine, Ivosidenib |