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Ref Type
Title Augtyro (repotrectinib) FDA Drug Label
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 4
Drug Name Trade Name Synonyms Drug Classes Drug Description
Repotrectinib Augtyro TPX-0005 ALK Inhibitor 32 JAK2 Inhibitor 17 ROS1 Inhibitor 20 SRC Inhibitor 31 Trk Receptor Inhibitor (Pan) 31 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 (
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...