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PMID

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Title

Gavreto (pralsetinib) FDA Drug Label

Journal	Vol	Issue	Date	Pages	Journal Short Title

URL

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213721

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Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
Pralsetinib	Pralsetinib	52	4

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
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).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
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...
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...

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