Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that IDH1 p.R132G status confers therapeutic sensitivity to Azacitidine, Ivosidenib in patients with Acute Myeloid Leukemia.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.