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Ref Type
PMID
Authors
Title Augtyro (repotrectinib) 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=218213
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Repotrectinib Repotrectinib 32 5
Drug Name Trade Name Synonyms Drug Classes Drug Description
Repotrectinib Augtyro TPX-0005 ALK Inhibitor 32 JAK2 Inhibitor 19 ROS1 Inhibitor 20 SRC Inhibitor 31 Trk Receptor Inhibitor (Pan) 32 Augtyro (repotrectinib) is a multi-kinase inhibitor that demonstrates strong activity against Ros1, Ntrk1/2/3, and Alk, and also inhibits Jak2 and Src family kinases, resulting in tumor cell death (PMID: 30093503, PMID: 32269053). Augtyro (repotrectinib) is FDA-approved for use in patients with advanced or metastatic ROS1 fusion-positive non-small cell lung cancer, and in adult and pediatric patients 12 years or older with advanced solid tumors harboring NTRK fusions (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion lung non-small cell carcinoma sensitive Repotrectinib FDA approved Actionable In a Phase I/II trial (TRIDENT-1) that supported FDA approval, Augtyro (repotrectinib) resulted in an objective response rate of 79% (56/71, 7 complete and 49 partial responses) and 38% (21/56, 3 complete and 18 partial responses), median duration of response of 34.1 and 14.8 months, and a median progression-free survival of 35.7 and 9.0 months in patients with TKI-naive and TKI-treated, ROS1 fusion-positive non-small cell lung cancer, respectively (PMID: 38197815; NCT03093116). 38197815 detail...