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Tibsovo
ivosidenib
Leucémie myéloïde aiguë ; Cholangiocarcinome
✅ Autorisé
✅
Aucune alerte active
Ce médicament ne fait l'objet ni de pénuries en cours, ni de lettres de sécurité, ni de rappels.
À quoi ça sert
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 (see section 5.1). 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.
⚠️ Sécurité des patients
No
Page officielle de l'EMA
https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo