Ivosidenib Approved in Combination With Azacitidine for Treatment of Acute Myeloid Leukemia

The FDA has approved ivosidenib (Tibsovo®, Servier Pharmaceuticals) in combination with azacitidine (Vidaza®, Celgene) for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are at least 75 years old or who have comorbidities preventing them from receiving intensive induction chemotherapy. "Mutant IDH1 catalyzes the production of D-2-hydroxyglutarate, leading to disruption in cellular metabolism and epigenetic regulation and contributing to oncogenesis," wrote Pau Montes...

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FDA Approves Ivosidenib for Advanced/Metastatic Cholangiocarcinoma

The FDA has granted approval to ivosidenib (Tibsovo®, Servier Pharmaceuticals) for patients with previously treated, locally advanced, or metastatic cholangiocarcinoma that has an isocitrate dehydrogenase-1 (IDH1) mutation. In addition, the FDA approved the Oncomine™ Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with ivosidenib. "Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahe...

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First-Line Ivosidenib Approved for Older Patients With AML

The FDA has now approved ivosidenib (Tibsovo®, Agios Pharmaceuticals, Inc.) as a first-line treatment for patients 75 years or older with acute myeloid leukemia (AML) and a susceptible IDH1 mutation who have comorbidities that prevent them from safely using intensive induction chemotherapy. Ivosidenib has previously been approved for patients with AML with no comorbidities. However, AML is mainly a disease found in older adults; nearly a third of all AML cases are diagnosed in those older than 7...

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