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|Therapy Name||Azacitidine + Sorafenib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Azacitidine||Vidaza||azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg||DNMT inhibitor (Pan) 5||Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).|
|Sorafenib||Nexavar||BAY 43-9006||CSF1R Inhibitor 25 FLT3 Inhibitor 55 KIT Inhibitor 51 PDGFR-beta Inhibitor 13 RAF Inhibitor (Pan) 16 RET Inhibitor 39 VEGFR2 Inhibitor 35||Nexavar (sorafenib) is a multikinase inhibitor with activity against several kinases, including RAF kinases, VEGFR2, VEGFR3, PDGFR-beta, KIT, FLT3, RET, and CSF1R, potentially resulting in decreased tumor growth (PMID: 18445656, PMID: 15466206, PMID: 21517818). Nexavar (sorafenib) is approved for metastatic differentiated thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FLT3 Y599_D600insSTDNEYFYVDFREYEY||acute myeloid leukemia||predicted - sensitive||Azacitidine + Sorafenib||Phase II||Actionable||In a Phase II trial, 93% (40/43) of acute myeloid leukemia patients harbored a FLT3-ITD and of the 37 patients that were evaluable, the combination therapy, Nexavar (sorafenib) and Vidaza (azacitidine), resulted in a 46% (17/37) response rate, which included 10 CRi, 6 CR, and 1 PR (PMID: 23613521).||23613521|
|FLT3 exon 14 ins||acute myeloid leukemia||sensitive||Azacitidine + Sorafenib||Guideline||Actionable||Nexavar (sorafenib) in combination with Vidaza (azacitidine) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02196857||Phase II||Azacitidine + Sorafenib||Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation||Completed||USA||0|