Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

European Commission (EC) has approved Tibsovo® (ivosidenib tablets) as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy 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.

Tibsovo, in associazione con azacitidina, è indicato per il trattamento di pazienti adulti con nuova diagnosi di leucemia mieloide acuta (LMA) con una mutazione dell'isocitrato deidrogenasi 1 (IDH1) R132 che non sono idonei per la chemioterapia di induzione standard - La monoterapia di Tibsovo è indicata per il trattamento di pazienti adulti con colangiocarcinoma localmente avanzato o metastatico con mutazione IDH1 R132, precedentemente trattati con almeno una linea di terapia sistemica

Tibsovo® is the first and only IDH1 inhibitor approved in Europe. It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.

link to Servier's Press release