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FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.

Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Apr 2024

Woods Ashley, Norsworthy Kelly J, Wang Xin, Vallejo Jonathon, Chiu Yuen Chow Edwin, Li Ruo-Jing, Sun Jielin, Charlab Rosane, Jiang Xiling, Pazdur Richard, Theoret Marc R, de Claro R Angelo

Abstract excerpt

On May 25, 2022, FDA approved a supplemental application for ivosidenib (Tibsovo; Servier) extending the indication in patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in older adults or those with comorbidities to include the combination with azacitidine. The efficacy of ivosidenib in combination with azacitidine was evaluated in Study AG120-C-009, a phase 3, multicenter, double-blind,...

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Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

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Identifiers

PMID: 38010220
DOI: 10.1158/1078-0432.CCR-23-2234
PMCID: PMC10984783

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