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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, 4 patients (3 men and a woman) were described, who developed drug resistance to enasidenib or ivosidenib during treatment for cancer. Additionally, amongst these four patients, a man developed IDH differentiation syndrome following treatment with enasidenib.
Case 1: A 54-year-old man developed resistance to ivosidenib during acute myeloid leukaemia treatment and IDH differentiation syndrome for enasidenib treatment. The man had been diagnosed with relapsed acute myeloid leukaemia (AML) 100 days after allogeneic bone marrow transplantation. He started receiving treatment with oral ivosidenib 500mg daily, 28 day cycle. After three such cycles, he was in complete remission. After 12 cycles, his bone marrow blast count and blood 2-hydroxyglutarate (2HG) levels...
- Harding JJ, et al. Isoform switching as a mechanism of acquired resistance to mutant isocitrate dehydrogenase inhibition. Cancer Discovery 8: 1540-1546, No. 12, Dec 2018. Available from: URL: http://doi.org/10.1158/2159-8290.CD-18-0877 - USA