Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized ivosidenib in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
This is written in the approval document as:
Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
Citation
Les Laboratoires Servier. Tibsovo (ivosidenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf. Revised January 2024. Accessed March 23, 2024.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 | 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 |