Article
FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an IDH1 Mutation.
Clinical cancer research : an official journal of the American Association for Cancer Research - 2 Sept 2025
Woods Ashley C, Pulte E Dianne, Wang Xin, Vallejo Jonathon, Chadda Ritu, Zheng Nan, Blanco Javier G, Dorff Sarah E, Li Hongshan, Liu Jiang, Okusanya Olanrewaju O, Pazdur Richard, Theoret Marc R, de Claro R Angelo, Norsworthy Kelly J
Abstract excerpt
On October 24, 2023, the FDA approved a supplemental application for ivosidenib (Tibsovo; Servier) for the treatment of adult patients with relapsed/refractory (R/R) isocitrate dehydrogenase 1-mutated myelodysplastic syndrome (MDS). The efficacy of ivosidenib in patients with R/R MDS was established in study AG120-C-001, an open-label, single-arm trial, based on the complete remission (CR) + partial remission...
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