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FDA approves ivosidenib plus azacitidine for certain patients with acute myeloid leukemia

FDA approved ivosidenib with azacitidine for untreated IDH1-mutated AML, based on AGILE trial showing improved EFS and OS. The combo has a known safety profile, marking a significant advancement for patients unsuitable for intensive chemotherapy.


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FDA approves ivosidenib plus azacitidine for certain patients with acute myeloid leukemia

FDA approved ivosidenib with azacitidine for untreated IDH1-mutated AML, based on AGILE trial showing improved EFS and OS. The combo has a known safety profile, marking a significant advancement for patients unsuitable for intensive chemotherapy.

FDA Approves Ivosidenib Plus Azacitidine for Previously Untreated IDH1-Mutated AML

FDA approved ivosidenib tablets (Tibsovo) with azacitidine for untreated IDH1-mutated AML in patients ≥75 or with comorbidities, based on AGILE study showing improved survival and response rates. Common AEs included nausea, vomiting, and diarrhea. This marks a significant advancement for patients ineligible for intensive chemotherapy.

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