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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 | ||||||||||||
Abstract Text |
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 (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 | predicted - sensitive | Revumenib | FDA approved | Actionable | In a Phase I trial (AUGMENT 101), Revuforj (revumenib) treatment demonstrated acceptable safety and resulted in a complete remission or complete remission with partial hematologic recovery (CR/CRh) rate of 30% (18/60) and median duration of response of 9.1 mo in adult and pediatric patients 1 year or older with acute leukemia harboring KMT2A rearrangements or NPM1 mutations, with a CR/CRh rate of 33% (15/46) and median time to CR/CRh of 2.0 mo in KMT2A rearranged patients (PMID: 36922593; NCT04065399). | 36922593 detail... |