Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

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