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Title | Rozlytrek (entrectinib) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212725 | ||||||||||||
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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Entrectinib | Entrectinib | 54 | 22 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Entrectinib | Rozlytrek | RXDX-101 | ALK Inhibitor 32 ROS1 Inhibitor 20 Trk Receptor Inhibitor (Pan) 32 | Rozlytrek (entrectinib) inhibits the activity of TrkA/B/C, Ros1 fusion proteins, and Alk, which leads to induction of apoptosis and inhibition of proliferation in cells expressing these kinases (PMID: 27003761). Rozlytrek (entrectinib) is FDA approved for use in patients with ROS1 positive non-small cell lung cancer and in adult and pediatric (1 year and older) patients with solid tumors harboring NTRK fusions without known acquired resistance 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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ROS1 fusion | lung non-small cell carcinoma | sensitive | Entrectinib | FDA approved - On Companion Diagnostic | Actionable | In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 77% (41/53), a median duration of response of 25 months in patients with ROS1 fusion positive non-small cell lung cancer, with median progression-free survival of 26 and 14 months for patients without (n=30) and with (n=23) CNS disease, respectively (PMID: 31838015; NCT02097810, NCT02568267). | detail... 31838015 |