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Title | Ensacove (ensartinib) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218171 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Ensartinib | Ensartinib | 45 | 8 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Ensartinib | Ensacove | X-396 | ALK Inhibitor 33 | Ensacove (ensartinib) is a small molecule inhibitor of ALK, which inhibits downstream signaling and potentially leads to decreased growth of ALK-expressing tumors (PMID: 21613408, PMID: 31628085). Ensacove (ensartinib) is FDA-approved for use in adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor (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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ALK rearrange | lung non-small cell carcinoma | sensitive | Ensartinib | FDA approved | Actionable | In a Phase III trial (eXALT3) that supported FDA approval, Ensacove (ensartinib) treatment significantly improved progression-free survival in patients with ALK-positive non-small cell lung cancer (25.8 vs 12.7 mo, HR 0.51, p<0.001) compared to Xalkori (crizotinib), and resulted in an intracranial response rate of 63.6% (7 of 11) in patients with target brain metastases at baseline, compared to 21.1% (4 of 19) with Xalkori (crizotinib) (PMID: 34473194; NCT02767804). | 34473194 detail... |