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| Title | Revuforj (revumenib) FDA Drug Label | ||||||||||||
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| URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218944 | ||||||||||||
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| Molecular Profile | Treatment Approach |
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| Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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| Revumenib | Revuforj | SNDX5613|SNDX 5613|SNDX-5613 | MEN1-KMT2A Inhibitor 8 | Revuforj (revumenib) inhibits the interaction between Menin and KMT2A (MLL), potentially resulting in antitumor activity and decreased proliferation of tumor cells with KMT2A (MLL) rearrangements or NPM1 mutations (PMID: 36922593, PMID: 36922589). Revuforj (revumenib) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia harboring KMT2A translocation, and in adult and pediatric patients 1 year and older with relapsed or refractory acute myeloid leukemia harboring susceptible NPM1 mutations (FDA.gov). |
| Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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| KMT2A rearrange | acute leukemia | sensitive | Revumenib | FDA approved | Actionable | In a Phase I/II trial (AUGMENT 101) that supported FDA approval, Revuforj (revumenib) treatment was well tolerated and resulted in a complete remission (CR) or CR with partial hematologic recovery (CR + CRh) rate of 22.8% (13/57, p=0.0036) and an overall response rate of 63.2% in adult and pediatric patients with relapsed/refractory acute leukemia harboring KMT2A rearrangements (PMID: 39121437; NCT04065399). | 39121437 detail... |