Tibsovo (ivosidenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	5
Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.	5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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
EMA (1)	IDH1 p.R132C	Cholangiocarcinoma	Ivosidenib
EMA (1)	IDH1 p.R132G	Cholangiocarcinoma	Ivosidenib
EMA (1)	IDH1 p.R132H	Cholangiocarcinoma	Ivosidenib
EMA (1)	IDH1 p.R132L	Cholangiocarcinoma	Ivosidenib
EMA (1)	IDH1 p.R132S	Cholangiocarcinoma	Ivosidenib