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FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation.

Clinical cancer research : an official journal of the American Association for Cancer Research - 6 Jan 2025

Woods Ashley C, Norsworthy Kelly J, Choe Moran, Gehrke Brenda J, Chen Haiyan, Vallejo Jonathon, Pan Lili, Jiang Xiling, Li Hongshan, Kraft Jeffrey, Liu Jiang, Charlab Rosane, Okusanya Olanrewaju O, Booth Brian, Pazdur Richard, Theoret Marc R, Angelo de Claro R

Abstract excerpt

On December 1, 2022, the FDA approved the new molecular entity olutasidenib (Rezlidhia, Rigel Pharmaceuticals), a small-molecule inhibitor of isocitrate dehydrogenase 1, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase 1 mutation as detected by an FDA-approved test. The efficacy of olutasidenib was established based on complete...

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Drug Approval
Drug Resistance, Neoplasm
Isocitrate Dehydrogenase
Leukemia, Myeloid, Acute

Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

Neoplasm Recurrence, Local

United States Food and Drug Administration

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Identifiers

PMID: 39475462
DOI: 10.1158/1078-0432.CCR-24-2196
PMCID: PMC11703669

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