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Title | Gavreto (pralsetinib) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213721 | ||||||||||||
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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Pralsetinib | Pralsetinib | 52 | 5 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Pralsetinib | Gavreto | BLU667|BLU-667 | RET Inhibitor 53 | Gavreto (pralsetinib) is a small molecule inhibitor that selectively targets activated Ret, which may result in antitumor activity including inhibition of tumor growth and tumor regression (PMID: 29657135). Gavreto (pralsetinib) is FDA approved for use in patients with metastatic RET fusion-positive non-small cell lung cancer, and in adult and pediatric patients 12 years of age and older with RET fusion-positive thyroid cancer who are radioactive iodine-refractory (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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RET fusion | thyroid cancer | sensitive | Pralsetinib | FDA approved | Actionable | In a Phase I/II trial (ARROW) that supported FDA approval, Gavreto (pralsetinib) treatment was well-tolerated, and resulted in an overall response rate (ORR) of 89% (8/9) in patients with advanced or metastatic RET fusion-positive thyroid cancer, with a median duration of response of 14.5 months, and 67% of responding patients continuing treatment (PMID: 34118198; NCT03037385). | 34118198 detail... |
RET fusion | lung non-small cell carcinoma | sensitive | Pralsetinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase I/II trial (ARROW) that supported FDA approval, Gavreto (pralsetinib) treatment was well-tolerated, resulting in an objective response rate of 61% (53/87) and 70% (19/27) in previously treated and treatment-naive patients with RET fusion-positive non-small cell lung cancer, respectively (PMID: 34118197; NCT03037385). | detail... 34118197 detail... |